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

Model Number G38490

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 11/12/2019

Event Type  Injury  

Event Description

According to the initial reporter- the stent would only deploy about 2/3 and the thumbwheel would not completely deploy the stent.They had to break up the white cartridge and manually deliver the stent by manipulating the wire/catheter.The stent was somewhat "scrunched" and they lined it with another manufacturer's stent.Post arterialgram showed a patent vessel.No additional procedures were required.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9355623
• MDR Text Key: 167661549
• Report Number: 3005580113-2019-00790
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)191212(10)C1477111
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2019
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C1477111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2019
• Distributor Facility Aware Date: 11/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2019
• Date Device Manufactured: 04/19/2018
• 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