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

Catalog Number UNKNOWN

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

Patient Problems Fistula (1862); Urinary Retention (2119)

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 removal prematurely in two patients one patient could not tolerate the subsequent storage bladder symptoms associated with the inserted metallic stent and required removal.Removal of the metallic stent in one patient as a result of the development of a vesicorectal fistula.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 31-mar-23 and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation.This file was opened to address the adverse events of ¿storage bladder symptoms¿ in 1 patient, and the formation of ¿vesicorectal fistula¿ another patient, as seen in the study ho et al 2020 ¿ ¿risk factors in the prediction of long-term patency of resonance metallic ureteric stent in malignant ureteric obstruction¿.The rms device of unknown rpn and lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to pr 374772 (emdr ref.- 3001845648-2022-00633) - ho et al 2020 -stent obstruction.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 list ¿fistula formation, including arterioureteral fistula¿ as well as ¿urinary symptoms (frequency, urgency, dysuria, haematuria)¿ as a potential adverse event associated with the use of the device.There is no 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: a definitive root cause could not be established.A possible root cause is attributed to inherent risk of the device, as the instructions for use list fistula formation as a potential adverse event associated with the use of the device.It was likely related to the patient¿s underlying condition ¿ a surgical procedure (laparoscopic low anterior resection) would have a significant impact on vascular circulation (meaning insufficient blood flow to the area), and adjuvant chemo-irradiation would have weakened the tissue surrounding bladder and rectum, and invasion or metastasis of the systemic recurrence of rectal cancer, all of which would have contributed to this vesicorectal fistula rather than resonance stent.An additional file (b)(4)- emdr ref.- 3001845648-2023-00230) was opened to capture the storage bladder symptoms following confirmation from our medical advisor that the fistula formation and storage bladder symptoms would result in different harms.Summary: complaint is confirmed based on customer and/or rep testimony.Fistula formations are a known adverse event associated with the use of the rms device.Repeated ureteral stenting may have also caused or contributed to the adverse events.According to the initial reporter, the patients required surgical intervention as a result of this occurrence in order to remove the stent prematurely.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: 15416649
• MDR Text Key: 299834173
• Report Number: 3001845648-2022-00640
• 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: 03/31/2023

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?: No
• 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: 08/16/2022
• 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: 04/26/2023
• 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