MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT

Model Number G38463

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Common name and pro-code: unknown.

Event Description

According to the initial reporter, patient was in interventional radiology for ir thrombolysis therapy and angiogram.During the procedure a zilver ptx 6mmx 40mm stent was used and it prematurely deployed.While this stent was bring retracted, using the filter and the filter wire, part of the stent sheared off near the left common femoral artery access site.Ct was ordered to determine exact location of sheared off site.Per ct: no definite intravascular foreign body is visualized.Questionable hyperdense fractured stent material surrounding the sheath.Patient was subsequently transferred to (b)(6) (account (b)(6) ) in the event further intervention was required.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9273979
• MDR Text Key: 177989914
• Report Number: 3005580113-2019-00717
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384634
• UDI-Public: (01)10827002384634(17)210115(10)C1613840
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: G38463
• Device Catalogue Number: ZISV6-35-125-6-40-PTX
• Device Lot Number: C1613840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2019
• Distributor Facility Aware Date: 10/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2019
• Date Device Manufactured: 05/15/2019
• 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