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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Bhatt et al, 2022 ¿ evaluation of renal function and stent durability following resonance stent placement for benign disease resonance stent placement - the etiology of benign ureteral obstruction (buo) was analyzed between the 2 subgroups.In subgroup a, iatrogenic ureteral stricture was the most common etiology.This developed most after endoscopic surgery (34.4%), followed by abdominopelvic surgery (9.4%) and radiation therapy (6.3%).The rest of the ureteral strictures in subgroup a were associated with extrinsic compression (9.37%), congenital obstruction (3.12%), and trauma (3.12%).In one-third of the patients (34.3%) in subgroup a, no specific cause for the stricture was provided or identifiable.In subgroup b, radiation-induced ureteral stricture (36.4%) was the most common etiology, followed by idiopathic ureteral stricture (27.3%), congenital ureteral stricture (18.2%) and extrinsic compression (18.2%).This complaint was opened to capture 38 cases of label use of a resonance stent device out of 38 patients.Total between pr 409008 & 409010 43 patients, 62.7 +/- 14.2 years, female 23, male 20, bmi (kg/m2) 28.0 ± 6.8, white 29, asian 8, other 6.

Manufacturer Narrative

Device evaluation: the resonance stent set devices 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 from the literature article bhatt et al,2022 ¿evaluation of renal function and stent durability following resonance stent placement for benign disease.¿ and will capture the cases of the stent being used off label.This complaint is related to (b)(4) which will capture the user error for stent indwelling time greater than 12 months.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: manufacturing records review could not be completed as the lot number is unknown.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.Review of historical data: it should be noted that the instructions for use, ifu0020, states the following: ¿intended use: used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿.There is evidence to suggest that the customer did not follow the instructions for use we know the devices were used for etiology of benign ureteral obstruction.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.As per the device ifu0020, the resonance stent device is intended to be used for ¿temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿ it is known that the devices were used for etiology or discovery of the causes of benign ureteral obstruction which is off label use.When the device is used outside of its intended use it is not possible to know how the device will perform.Confirmation of complaint: complaint is confirmed based on customers testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer the device was not used to treat extrinsic ureteral obstruction.Complaint is confirmed based on customer and/or rep testimony.A definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.As per the device ifu, the resonance stent device is intended to be used for ¿temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿ it is known that the devices were used for etiology or discovery of the causes of benign ureteral obstruction which is off label use.When the device is used outside of its intended use it is not possible to know how the device will perform.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for similar events.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 22-apr-2024.

• 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: 17823285
• MDR Text Key: 324329084
• Report Number: 3001845648-2023-00736
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/22/2024

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 05/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female