MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number G57449

Device Problems Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

Common name - qan.Pma # - p200023.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

A patient of undisclosed age and gender underwent a placement of vena stent through right femoral vein approach in which the zilver vena venous self-expanding stent, g57449, was used.Caudal portion of stent foreshortened upon deployment.

Manufacturer Narrative

Common name - qan, pma # - p200023.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to imagining review completed on 23-nov-2021 which indicates user error: imaging review completed on 23-nov-21: impression: the complaint of excessive stent shortening is not confirmed.The stent did land 12mm short of its intended target.This was because the target was set on the nearly straight course of the undeployed stent rather than the implantation vein¿s curved path.

Manufacturer Narrative

Common name - qan.Product code - qan.Pma/510(k) # p200023.Device evaluation: the zvt7-35-80-16-140 device of lot number c1849096 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation ¿ n/a document review prior to distribution zvt7-35-80-16-140 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.A review of the manufacturing records for zvt7-35-80-16-140 of lot number c1849096 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1849096.It should be noted that the instructions for use ifu0091-7 states the following: ¿the chosen stent diameter should be oversized 1-4mm with respect to the estimated vessel diameter as determined by the best available assessment¿.There is evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer impression: the complaint of excessive stent shortening is not confirmed.The stent did land 12mm short of its intended target.This was because the target was set on the nearly straight course of the undeployed stent rather than the implantation vein¿s curved path.Root cause review: a definitive root cause of user error was identified from the available information.As per the instructions for use ifu0091-7, ¿the chosen stent diameter should be oversized 1-4mm with respect to the estimated vessel diameter as determined by the best available assessment¿.The image review confirmed that the selected stent was shorter than required for the lesion that was being treated.The customer¿s testimony could not be confirmed, however the complaint is confirmed based on the failure verified in the investigation.The complaint of stent shortening could not be confirmed as the defect could not be verified in the images.However, user error was confirmed in the images.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 potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12795851
• MDR Text Key: 284988822
• Report Number: 3001845648-2021-00801
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)240713(10)C1849096
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2022

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 Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1849096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 10/22/2021; 10/22/2021
• Supplement Dates FDA Received: 12/15/2021; 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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