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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Obstruction/Occlusion (2422)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Chen et al 2021, management of 6fr polymer ureteric stent failure in the setting of malignant ureteric obstruction.347 patients had jj stent inserted for malignant ureteric obstruction and had at least one stent exchange between 2010 and 2020 (including planned and unplanned).48 patients (63 ureters) experienced stent failure with 6fr polymer ureteric stent and was managed with stent exchange.Group a was managed by an exchange to a new 6 fr polymer stent.9 patients (9 ureters).Group b was managed by an exchange to 8fr polymer stents 30 patients (41 ureters).Group c was managed by an exchange to 6fr resonance® metallic stent 9 patients (13 ureters).This file will capture the stent failure requiring a nephrostomy tube and off label use of twin stenting with the resonance® metallic stent.2 patients had twin 6fr stents inserted after single 6fr polymer stents failure.The other patient had ongoing obstruction with twin 6fr stents and had nephrostomy tube inserted 48 hours later.347 patients had jj stent inserted for malignant ureteric obstruction and had at least one stent exchange between 2010 and 2020 (including planned and unplanned).

Manufacturer Narrative

Device evaluation: the resonance stent set 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 in the literature article chen et al 2021 ¿management of 6fr polymer ureteric stent failure in the setting of malignant ureteric obstruction¿.This study aims to identify the best second-line stent option when 6fr polymer stent fails, before committing to nephrostomy.Stent failure was defined by unplanned stent exchange due to clinical, radiological or biochemical evidence of stent obstructions.The study investigates 347 patients divided into three groups.Group a, group b and group c.Group a was managed by an exchange to a new 6 fr polymer stent 9 patients (9 ureters).Group b was managed by an exchange to 8fr polymer stents30 patients (41 ureters).Group c was managed by an exchange to 6fr resonance® metallic stent 9 patients (13 ureters).48 patients (63 ureters) experienced stent failure with 6fr polymer ureteric stent and was managed with stent exchange.2 patents was fitted with twin 6fr stents after single 6fr polymer stent failure.This file captures the off label use of twin stent insertion of rms devices.Lab evaluation: n/a.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all resonance stent set 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.Image review: n/a.Impression: n/a.Root cause review: a definitive root cause of off label use was identified from the available information.The physician opted for twin stenting of rms devices.Off label used complaints are considered to be unforeseen misuse.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, 2 patients had twin 6fr stents inserted after single 6fr polymer stents failure.The other patient had ongoing obstruction with twin 6fr stents and had nephrostomy tube inserted 48 hours later.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 13252619
• MDR Text Key: 294137476
• Report Number: 3001845648-2022-00014
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 04/15/2022
• 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