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

Model Number	G24935
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Occlusion (1984); Stenosis (2263)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Report Number: 3005580113-2019-00347
• Device Sequence Number: 11587026
• Product Code: NIU
• UDI-Device Identifier: 10827002249353
• UDI-Public: (01)10827002249353(17)160519(10)C1129832
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2019
• Report Date (Section F): 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
• Operator of Device: 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
• Distributor Facility Aware Date: 08/21/2019
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Date Report Sent to FDA: 09/09/2019