MAUDE Adverse Event Report: COOK INC PATERSON-FORRESTER SUBCUTANEOUS URINARY DIVERSION STENT; FAD STENT, URETERAL

Catalog Number SDSB-856500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Tract Infection (2120); Discomfort (2330); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Event Description

As reported in the literature by brophy et al.(2021), a retrospective review was conducted of patients who underwent extra-anatomical stent (eas) placement between november 2012 and january 2021.Ten patients underwent a total of 33 eas procedures, using the paterson-forrester subcutaneous urinary diversion stent.The mean age at the time of the primary procedure was 58 years (range 43-63).Three patients were male and seven were female.All patients had benign ureteric obstruction, with retroperitoneal fibrosis the most common cause of obstruction.All patients had a nephrostomy in place, and all had failed trials of internalizing the nephrostomy.All patients had chronic kidney disease with a median estimated gfr (glomerular filtration rate) of 36 (range was 10-77).All had undergone exchange of their nephrostomy catheter within one month of primary eas insertion.Primary eas insertion was performed under general anesthesia, using cystoscopy and fluoroscopic guidance.Antibiotics were given prophylactically.Subsequent exchanges were performed under either general or spinal anesthesia.During the initial procedure, a subcutaneous tract is made in stages and the eas is passed through a sheath with the proximal end placed in the renal pelvis.A needle puncture is then made in the bladder and using cystoscopy, a guidewire and sheath are inserted into the bladder, and the distal end of the stent is inserted via the sheath.The incisions are then closed.Outpatient follow-up was performed at six weeks and routine exchanges were planned at twelve months.Case 6 in article: the patient developed irritative bladder symptoms requiring exteriorization of the distal end of the stent to the anterior abdominal wall.The patient also underwent a benign nephrectomy due to recurrent urinary tract infections and gradual functional decline of the left kidney (from 43% to 31%).In the same article, one patient (case 1) experienced migration of the stent- will be reported under patient identifier (b)(6).One patient (case 9) developed urosepsis- will be reported under patient identifier (b)(6).One patient experienced migration (case 10) with cutaneous erosion- reported under patient identifier (b)(6).One patient (case unknown) experienced bladder irritation requiring exteriorization of the stent- reported under patient identifier (b)(6).Reference: brophy, et al.(2021).Extra-anatomical stents in benign ureteric obstruction: experience and outcomes.Journal of endourology.Https://doi.Org/10.1089/end.2021.0340.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Event description: as reported in the literature by brophy et al.(2021), a retrospective review was conducted of patients who underwent extra-anatomical stent (eas) placement between (b)(6) 2012 and (b)6) 2021.Ten patients underwent a total of 33 eas procedures, using the paterson-forrester subcutaneous urinary diversion stent.The mean age at the time of the primary procedure was 58 years (range 43-63).Three patients were male and seven were female.All patients had benign ureteric obstruction, with retroperitoneal fibrosis the most common cause of obstruction.All patients had a nephrostomy in place, and all had failed trials of internalizing the nephrostomy.All patients had chronic kidney disease with a median estimated gfr (glomerular filtration rate) of 36 (range was 10-77).All had undergone exchange of their nephrostomy catheter within one month of primary eas insertion.Primary eas insertion was performed under general anesthesia, using cystoscopy and fluoroscopic guidance.Antibiotics were given prophylactically.Subsequent exchanges were performed under either general or spinal anesthesia.During the initial procedure, a subcutaneous tract is made in stages and the eas is passed through a sheath with the proximal end placed in the renal pelvis.A needle puncture is then made in the bladder and using cystoscopy, a guidewire and sheath are inserted into the bladder, and the distal end of the stent is inserted via the sheath.The incisions are then closed.Outpatient follow-up was performed at six weeks and routine exchanges were planned at twelve months.Case 6 in article: the patient developed irritative bladder symptoms requiring exteriorization of the distal end of the stent to the anterior abdominal wall.The patient also underwent a benign nephrectomy due to recurrent urinary tract infections and gradual functional decline of the left kidney (from 43% to 31%).In the same article, one patient (case 1) experienced migration of the stent- will be reported under patient identifier 354818.One patient (case 9) developed urosepsis- will be reported under patient identifier 354822.One patient experienced migration (case 10) with cutaneous erosion- reported under patient identifier 354823.One patient (case unknown) experienced bladder irritation requiring exteriorization of the stent- reported under patient identifier (b)(6).Reference: brophy, et al.(2021).Extra-anatomical stents in benign ureteric obstruction: experience and outcomes.Journal of endourology.Https://doi.Org/10.1089/end.2021.0340 investigation - evaluation reviews of instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of relevant manufacturing documents was conducted.It was concluded that current controls for manufacturing are in place to assure functionality, device integrity, and device sterility prior to shipping.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: warnings/precautions caution: maximum indwelling time is three (3) months.Note: it is recommended that the stent be fluoroscopically monitored every month cook could not determine a cause of the reported event from the available information.Causes for the event including patient factors/condition, user/procedural issues, concomitant device use, manufacturing issues, and/or device failure were unable to be ruled out during the investigation.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: PATERSON-FORRESTER SUBCUTANEOUS URINARY DIVERSION STENT
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13598976
• MDR Text Key: 290778174
• Report Number: 1820334-2022-00309
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K961371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SDSB-856500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SENSOR GUIDEWIRE (BOSTONSCI), ALKEN DILATORS
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female