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

Catalog Number UNKNOWN

Device Problems Material Too Rigid or Stiff (1544); Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.Annex g: (b)(4): stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Fu, 2020, zilver vena and stent characteristics of 32 patients with early (<14 days) iliofemoral stent occlusion.Patients diagnosed with early in-stent thrombosis after iliofemoral stenting were reviewed in this retrospective analysis.Patients with a recurrence of symptoms or the detection of thrombus in stents within 14 days after stent implantation were included.Patients with stents placed below the orifice of the deep femoral vein were excluded.The second factor was stent-related failure: there were five cases of overlapping locations of two stents with sharp angulation; 4 stents were placed in these nine patients after successful thrombolysis.This file will capture 5 cases of stent angulation requiring thrombolysis and potential re-stenting.

Manufacturer Narrative

Common name: qan.Product code: qan.Pma/510(k) #: p200023.The zilver vena venous self expanding stent (zvt-7) devices of unknown lot numbers involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.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 zilver vena venous self expanding stent 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.There is evidence to suggest the user did not follow the ifu (ifu0047-5).The ifu states: in relation to the operator, the distal are of narrowing should be stented first, followed by the proximal locations (i.E., a second stent should be paced proximally to the previously placed stent).It is detailed in the literature that a larger proximal stent was placed before a smaller distal stent.A definitive root cause of user error was identified from the available information.It is detailed in the literature that a larger proximal stent was placed before a smaller distal stent.The instructions for use outline that the distal area of narrowing should be stented first, followed by the proximal locations.To avoid angulation, the literature acknowledges that priority should be given to the placement of the distal stent with a smaller diameter if multiple stents are needed.Then, a larger stent at the proximal location can be inserted into the smaller size to decrease the angulation.The complaint is confirmed based on customer testimony.According to the initial report a stent was placed after successful thrombolysis 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; national technology park; 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: 11640351
• MDR Text Key: 261307869
• Report Number: 3001845648-2021-00290
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• 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
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/16/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 46 YR