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 Problem Sepsis (2067)

Event Date 06/06/2021

Event Type  Injury  

Event Description

(b)(6), 2021, rms and risk factors for primary failure of metallic ureteral stents: experience from a tertiary center in our hospital, the retrograde method of stent insertion is performed under general anesthesia by urologists.Initially, an introduction set similar to an 8f/10f dilator is passed over a guidewire into the renal pelvis.The wire and inner catheter are removed, and the resonance stent is passed through the 10f introducer sheath.The inner catheter is then used to push the stent proximally until the pigtail is placed in the renal pelvis.Finally, the 10f sheath is retracted with the inner catheter held in place until the distal pigtail is deployed in the bladder.The whole procedure is performed under fluoros-copy.A total of 124 stents were inserted into 96 patients because there were 28 patients having bilateral stents.Sepsis was noted in three patients.These were managed conservatively.

Manufacturer Narrative

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

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.Complaint was raised in the literature article hsu 2021 "rms and risk factors for primary failure of metallic ureteral stents: experience from a tertiary center".Complaint files (b)(4) were raised as a result of the literature article.(b)(4) (report reference number 3001845648-2021-00758) was raised to capture 21 cases off label rms being placed for intrinsic compression.(b)(4) (report reference number 3001845648-2021-00759) was raised to capture 15 cases stent failure + intervention.(b)(4) was raised to capture various minor ae¿s.(b)(4) (report reference number 3001845648-2021-00761) was raised to capture 35 cases of symptomatic utis.This complaint was raised to capture 3 cases sepsis.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.It should be noted that the instructions for use (ifu0020) states the following: ¿potential adverse events associated with indwelling ureteral stents include: infections, urinary symptoms (frequency, urgency, incontinence, dysuria, hematuria), urinary tract tissue erosion¿.¿warnings individual variations of interaction between stents and urinary system are unpredictable¿.Image review n/a.Impression n/a.Root cause review: a definitive root cause could not be determined from the available information.Sepsis is a known risk captured in the cer as a less common, more severe complication.The instances are not available.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required hospitalisation/prolong hospitalisation.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: 12717851
• MDR Text Key: 284300886
• Report Number: 3001845648-2021-00760
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 05/23/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue 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: 06/06/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 06/20/2022
• 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): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 55 KG