PM-25843
NovoFlowTM Reinforced Ureteral Stent Brief Statement
Indications for use
The NovoFlowTM Reinforced Ureteral Stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.
Contraindications
Do not attempt stent placement in a patient with suspected ureteral avulsion.
Allergy to any component of the device.
Violent sports or strenuous physical activities are not recommended during stenting period. The practice of sport should be evaluated by the physician.
Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
Untreated progressive infections of the upper urinary tract.
Uncontrolled haemostasis disorder (relative contraindication).
The safety of some endourological procedures should be evaluated in pregnant women
Warnings and Precautions
These devices must only be used by trained and experienced physicians.
Physicians must inform patients of the possible undesirable side effects.
Physicians should evaluate the allergic background of the patient before use.
Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them.
Potential Complications
The following events have been reported with double loop ureteral stents although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: pain, discomfort, sexual dysfunction, infection (e.g., urinary tract infection, pyelonephritis, severe infection, sepsis), tissue lesion (e.g., mucosal irritation, erosion, laceration, perforation of the renal pelvis, ureter or bladder), urinary symptoms (e.g., frequency, urgency, dysuria…), migration, encrustation, obstruction, hematuria, hemorrhage, fragmentation, reflux, knot, and hydronephrosis.
Some other events may be related to the procedure, particularly if the devices are not used as recommended amongst which:
- related to the guidewire: perforation of the urinary tract or close organs, bleeding, hemorrhage, mucosal irritation, tissue lesion, breakage, foreign object in the body, infection, guidewire knotting or looping or kinking, guidewire entrapment, or ureteral avulsion.
- related to the pusher: mucosal irritation, perforation, foreign object in the body, infection or prolonged procedure in case of difficult detachment from the stent.
Advice to the Patient
The physician should educate the patients on their implanted stent, the need for regular monitoring and the planned removal date. Practice of strenuous activities or violent sport should be avoided.
The patients should be informed on potential side effects (e.g., discomfort during physical activities or urination, frequent or urgent needs to urinate, or sexual dysfunction…). They should be advised to immediately contact the attending physician if any of the following symptoms are noted: any sustained pain, cloudy urine, bladder irritation, blood in the urine or any sign or symptoms that they are having difficulty with urination.
The risks and benefits of using NovoFlow™ Reinforced Ureteral Stent should be considered in patients.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Minneapolis, MN
11/15/2022
PM-24600
