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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Use of Device Problem (1670)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Ho et al 2020 - risk factors in the prediction of long-term patency of resonance metallic ureteric stent in malignant ureteric obstruction.This study aimed to identify risk factors associated with resonance metallic ureteric stent failure due to malignant disease progression, and to propose a simple scoring system for the prediction of long-term patency of metallic stent in patients with muo.Resonance metallic ureteric stents were inserted in a standardized retrograde fashion under both cystoscopic and fluoroscopic guidance.Retrograde pyelogram was first carried out in all patients to confirm level of obstruction.Ureteric length was measured by catheterizing the ureter with an open ended ureteric catheter marked with a visual scale measurer.Gentle ureteric dilation (either by balloon or teflon ureteric dilators) was performed at the discretion of the operating surgeon if required.Insertion of resonance metallic ureteric stents were as per manufacturer's instructions.The position of the proximal coil of the metallic ureteric stents were confirmed with fluoroscopy and distal coil by cystoscopy.All metallic ureteric stents used were 6 fr in size, with lengths measuring from 22 to 26 cm chosen according to ureteric length measured.All metallic ureteric stents were revised yearly as per manufacturer's recommendations.This complaint was opened to capture stent obstruction - 41 (33.1%) renal units ultimately progressed to ureteric obstruction despite the metallic stents.Required subsequent insertion of nephrostomies.

Manufacturer Narrative

Device evaluation the unknown resonance stent set devices of unknown lot number involved in this complaint were not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created from the attached journal article.Complaint files (b)(4) / mdr ref#3001845648-2022-00633 and (b)(4) / mdr ref#3001845648-2022-00640 were raised from this paper.Lab evaluation ¿ n/a manufacturing records: 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 rms devices are subjected to 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 historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and/label: it should be noted that the instructions for use, ifu0020, states the following: ¿the stent must not remain indwelling more than 12 months.¿.There is evidence to suggest that the customer did not follow the instructions for use from clinical input received we know that the stents were left indwelling more than 12 months.Image review ¿ n/a root cause analysis: a definitive root cause of use error can be identified from the literature paper it is known the stents were left indwelling greater than 12 months.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation according to the initial reporter there was, 41 cases of stent obstruction.The complaint is confirmed based on customer testimony.A definitive root cause of use error was identified.All patients would have required subsequent insertion of nephrostomies.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 on 05-dec-2023.

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 15409775
• MDR Text Key: 299773088
• Report Number: 3001845648-2022-00633
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 08/16/2022
• Supplement Dates FDA Received: 12/19/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female