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

Model Number G24935

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Occlusion (1984); Stenosis (2263)

Event Date 05/21/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 (1356 days post-procedure), the patient was diagnosed with an occlusion/restenosis within the study lesion requiring intervention.Treatment included balloon angioplasty.The physician indicated the event was possibly related to both the study product and procedure.The pre-existing condition of systemic atherosclerosis caused or contributed to the event.The site has not completed the secondary intervention form, no further information is available.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8974871
• MDR Text Key: 156909632
• Report Number: 3005580113-2019-00347
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002249353
• UDI-Public: (01)10827002249353(17)160519(10)C1129832
• 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: 09/09/2019

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: 05/19/2016
• Device Model Number: G24935
• Device Catalogue Number: ZIV6-35-125-6-100-PTX
• Device Lot Number: C1129832
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2019
• Distributor Facility Aware Date: 08/21/2019
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Date Device Manufactured: 07/09/2015
• 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: 83 YR