MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510k #: k181971.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported in the journal article "a tertiary experience of ileal-ureter substitution: contemporary indications and outcomes", appearing in the november 2015 (online) issue of the scandinavian journal of urology, that a cook bander ureteral diversion stent migrated through the anastomosis and subsequently the patient developed an unilateral anastomotic leak.Sequence of events as follows: a female patient underwent a bilateral ileal-ureter substitution procedure using a cook bander ureteral diversion stent set to treat bilateral ureteric stricture due to ischemic fibrosis.In the procedure, bilateral ileal interposition chutes were created using a 40cm ileal u-loop.An unspecified time later, the patient developed a post-operative paralytic ileus (resolved with total parental nutrition), subsequent re-stricture, and a small pelvic collection (abscess) from an anastomotic leak related to migration of the bander stent through the anastomosis.There was no deterioration in renal function (as measured by follow-up estimated glomerular filtration rate (gfr).The patient underwent a successful revision of the anastomotic stricture by advancement of the ileal chute with a favorable outcome.

Manufacturer Narrative

Investigation - evaluation.It is reported in the journal article "a tertiary experience of ileal-ureter substitution: contemporary indications and outcomes", appearing in the november 2015 (online) issue of the scandinavian journal of urology, that a cook bander ureteral diversion stent migrated through the anastomosis and subsequently the patient developed an unilateral anastomotic leak.The part number and lot number for the bander stent set were not provided.The female patient has a complicated medical/surgical history including postpartum sepsis following the birth of her fourth child, emergency sub-total hysterectomy and bilateral salpingo-oophorectomy, a second laparotomy and washout post-operatively and excision of the cervix.The patient underwent a bilateral ileal-ureter substitution procedure using a cook bander ureteral diversion stent set to treat bilateral ureteric stricture due to ischemic fibrosis (related to complicated medical/surgical history described above).In the procedure, bilateral ileal interposition chutes were created using a 40cm ileal u-loop.An unspecified time later, the patient developed a post-operative paralytic ileus (not related to cook bander ureteral stent-resolved with total parental nutrition), subsequent re-stricture, and a small pelvic collection (abscess) from an anastomotic leak related to migration of the bander stent through the anastomosis.There was no deterioration in renal function (as measured by follow-up estimated glomerular filtration rate (gfr).The patient underwent a successful revision of the anastomotic stricture by advancement of the ileal chute with a favorable outcome.Reviews of the instructions for use (ifu), and quality control data were conducted during the investigation.The complaint originates from a clinical article that was published in november 2015.Consequently, there is not a complaint device associated with the investigation.The evidence from the complaint file and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.A review of the device history record and complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provided with the device state, "sof-flex® and silicone bands are used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions." in this case, the bander ureteral stent was used outside of its intended use listed on the product labeling when it was used to treat ureteric stricture in a bilateral ileal interposition chute procedure (creation of new ureters out of small intestine).This patient had a complicated surgical history likely leading to diffuse scarring/stricture throughout the pelvic cavity.The patient was known to have bilateral ureteral ischemic fibrosis (the indication for surgery).Since the bander ureteral stent was being used within a created ileal conduit, it was being used within tissue it was not intended for (native ureter).It is likely that the inner diameter of a created ileal chute would be much larger than that of a native ureter.This larger ileal chute is surgically attached to the patient¿s kidney at the same point where the fibrotic/ischemic ureter was previously removed.It is possible that this (kidney) tissue was also slightly fibrosed further increasing the possibility of anastomotic failure, allowing the bander stent to migrate outside of the anastomosis (and leading to the small pelvic collection).Based on the information available, the factors likely contributing to this event include patient condition and off-label use of the device.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.

Event Description

There is no new patient or event information to report.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10345259
• MDR Text Key: 201911664
• Report Number: 1820334-2020-01388
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention