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

Model Number G57447

Device Problem Fracture (1260)

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

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Product code: qan.

Event Description

"access was right and left femoral vein, and jugular vein with 18fr x 35cm cook sheaths in both the ij & right femoral vein.There was an 8 fr sheath in the left femoral vein.The patient had a 10-year-old celet ivc filter in that was removed prior to placing stents.Once removed, the physician uses ivus to measure the ivc which measured a 14.2mm diameter.He decided to place a 16x60 zilver vena in the ivc right at the confluence from the right femoral vein.Then followed that stent with two 14x140 stents in the common iliac veins.These were all placed from the femoral vein access.The physician used ivus again to confirm placement.He then had to retrieve a piece of filter that had broken off in the liver during the ivc filter retrieval and realized the zilver vena stent that was placed in the ivc had migrated up higher in the ivc.He did mention it could have been dragged up from the catheter he was using to retrieve the piece of ivc filter.The physician tried pushing the stent down with a large snare then decided it needed to come out.He used the large snare from both above and below through the 18fr sheaths to snare and remove the zilver vena stent from the patient.The stent did fracture in 3 pieces but they were able to retrieve all pieces of the stent.The patient did great, no additional surgeries were needed and the final images looked good.I have attached pictures of the initial stents, the migrated stent, the removed stent, and the final image.".

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12514477
• MDR Text Key: 273100306
• Report Number: 3005580113-2021-00108
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574479
• UDI-Public: (01)10827002574479(17)240119(10)C1792883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021,09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: G57447
• Device Catalogue Number: ZVT7-35-80-16-60
• Device Lot Number: C1792883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Date Device Manufactured: 01/19/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR