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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Khoo et al 2021 (resonance) ¿ ¿single-centre experience with three metallic ureteric stents (allium® urs, memokath¿-051 and resonance®) for chronic ureteric obstruction¿.Operating theatre records were reviewed to identify patients who had undergone metallic ureteric stent insertion with either allium® urs, memokath¿-051 or resonance® for cuo.Post-operatively, all patients were reviewed in clinic with serum creatinine, abdominal x-ray, and mercaptoacetyltriglycine-3 (mag-3) renogram at 6 weeks, and reviewed again with serum creatinine and abdominal x-ray at 3 months and then every 6 months.If there was clinical concern of stent failure, ct urogram (if estimated glomerular filtration rate (egfr) =30ml/min/1.73m2) or urinary tract ultrasound (if egfr <30ml/min/1.73m2) was performed.At each follow-up appointment, patient-reported stent symptoms (including irritative voiding symptoms, pain, and haematuria) were noted.Resonance: 29 patients, 58 sies) 6 cases of obstruction reported.(as per figure 5a 10% of 58 sie's = approx.6 devices).As per clinical input: require intervention/additional procedures to prevent permanent impairment/damage.

Manufacturer Narrative

Device evaluation: the unknown devices of unknown lot number involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.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 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.It should be noted that the instructions for use (ifu0020-18) lists diminished urine drainage/ stent occlusion as a known potential adverse event associated with rms procedures.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to patient pre-existing conditions.As per the ifu, diminished urine drainage/ stent occlusion is listed as a known potential adverse event associated with rms procedures.Summary: the complaint is confirmed based on customer testimony.As per clinical input the patients would have required intervention/additional procedures to prevent permanent impairment/damage.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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 12713839
• MDR Text Key: 279593807
• Report Number: 3001845648-2021-00762
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/30/2022

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?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 07/28/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female