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

Model Number	G57451
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode) qan.
Event or Problem Description
As reported to customer relations via complaint email "during the procedure he used alpha back.I asked him if that device contraindicated in a stent.He declared he didn¿t know whether it was or wasn¿t.I later learned that the alphaback rep was there for the case.He passed the thrombectomy device through the stent and cleared some clot out out and images show improvement but clot was noted in the ivc filter.He went back in with the thrombectomy device to clear out the clot in the filter.He stated he turned had the machine as he pushed the device up.After he was done he pulled the device back and noted the stent was potentially fractured/ migrated/ and/ or folded on itself.Ct scan later confirmed that the stent was at least folded on itself." note: zilver vena deployed on april 20th by dr (b)(6) at lincoln (b)(6).Got the call from dr (b)(6) at 3:38pm.He said the stent went down and clotted off.The lot number in that stent is c1846966.His complaint was that the stent migrated into the ivc during his thrombectomy procedure done on (b)(6) 2022.Answer to additional question: there is no complaint device to return.The complaint was iatrogenic migration of a stent implant 6 days after deployment.This was due to thrombosis of the stent and native vessels a day after stent deployment.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14492189
• Report Number: 3005580113-2022-00061
• Device Sequence Number: 20335609
• Product Code: QAN
• UDI-Device Identifier: 10827002574516
• UDI-Public: (01)10827002574516(17)240705(10)C1846966
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2022
• Report Date (Section F): 05/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2024
• Device Model Number: G57451
• Device Catalogue Number: ZVT7-35-120-14-100
• Device Lot Number: C1846966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2022
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2022
• Date Device Manufactured: 07/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown