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

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.(b)(4).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 patency rate was 90% (27/30), and three cases of reocclusion occurred.One was detected in the second month with thrombosis in the stent.The other two cases were detected in months 6 and 8 as a result of stenosis of the stented sections.All were treated successfully with thrombolysis, balloon angioplasty, or stenting.This complaint will capture 2 cases of restenosis in months 6 and 8 as a result of stenosis of the stented sections.

Event Description

Final mdr being submitted fue to completion of the investigation on 29-oct-21.

Manufacturer Narrative

Pma/510(k) #: p200023 product code: qan device evaluation 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 no evidence to suggest the user did not follow the ifu (ifu0047-5).A definitive root cause could not be identified from the available information.A possible root cause could be related to patients pre-existing conditions.It is known that that the patients included in the study has suffered with either acute or chronic deep vein thrombosis or has been treated for post thrombotic syndrome or iliac venous compression syndromes.It should be noted that restenosis is listed as a potential adverse event in the instructions for use.The complaint is confirmed based on customer testimony.According to the initial report all patients were treated successfully with thrombolysis, balloon angioplasty, or stenting complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 11640027
• MDR Text Key: 261688736
• Report Number: 3001845648-2021-00292
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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: 10/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 11/25/2021
• 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