MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Stainer, 2017, rms and the use of cook resonance metallic ureteral stent in cases of obstructive uropathy from persistent neoureteral stenosis, following kidney transplantation.Case 1 a 45-year-old lady underwent an uneventful live related donor renal transplantation, however, postoperatively she developed obstructive uropathy with marked hydronephrosis.Due to persistent obstruction, despite open surgery and following multiple distal stent migrations and expulsions, necessitating frequent nephrostomy insertion, she underwent an effective retrograde insertion of a 12 cm 6f cook resonance metallic ureteral stent, under general anesthesia.There was difficult retrograde access of the transplanted ureter and initial stent insertion had a radiation exposure of 2854 cgy$cm2.Various techniques were attempted to pass the guidewire and insert the stent.These included the use of a rigid cystoscope, a semirigid ureteroscope, and a flexible cystoscope.We found the best way was to use the flexible cystoscope.Subsequent stent exchanges were easier and quicker to perform with the techniques being improved upon each time.We saw an 80% in the fourth stent exchange to 556 cgy cm2.Total operating time for the first insertion was 140 minutes, which has progressively improved over the subsequent three further stent exchanges, with the most recent taking just 55 minutes (60% reduction).Following 3 years of follow-up, relief of obstructive uropathy has been maintained.The patient tolerates the stent extremely well, with no radiologic or clinical evidence of complications.Annual stent exchange, on three separate occasions, has been uneventful, with significantly decreased operative and radiation exposure times.No adverse effects reported as occurring.Off-label use for non extrinsic source of obstruction.

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 03-mar-2023.

Manufacturer Narrative

Device evaluation: the unknown device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This complaint was raised from literature article stainer et al 2017 ¿rms and the use of cook resonance metallic ureteral stent in cases of obstructive uropathy from persistent neoureteral stenosis, following kidney transplantation.¿.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review: manufacturing records review could not be completed as the lot number is unknown.However, prior to distribution all rms devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Review of historical data: historical data was not reviewed as the lot number is unknown.It should be noted that the instructions for use, ifu0020, states the following: ¿intended use: used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿.There is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause review: definitive root cause of off label use can be concluded based on customer/rep testimony.It is known that the device was used for obstructive uropathy, which is considered a non-extrinsic obstruction.As per ifu, the rms device is intended to be used for ¿temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿ summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.As per the literature article, ¿following 3 years of follow-up, relief of obstructive uropathy has been maintained.The patient tolerates the stent extremely well, with no radiologic or clinical evidence of complications.Annual stent exchange, on three separate occasions, has been uneventful, with significantly decreased operative and radiation exposure times.¿ complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15416601
• MDR Text Key: 301498273
• Report Number: 3001845648-2022-00636
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 08/16/2022
• Supplement Dates FDA Received: 03/30/2023
• 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
• Patient Age: 45 YR
• Patient Sex: Female