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

Model Number	G38491
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the initial reporter, "when attempting to deploy the stent, antegrade and ipsilateral.The stent elongated about 90mm's.Due to the delivery system getting caught in the valve on the short sheath.They brought the patient 2 hours later as the facility decided they needed to put another stent in to cover the elongated zilver ptx.".

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8957933
• Report Number: 3005580113-2019-00341
• Device Sequence Number: 2417956
• Product Code: NIU
• UDI-Device Identifier: 10827002384917
• UDI-Public: (01)10827002384917(17)190918(10)C1557555
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2019
• Report Date (Section F): 09/03/2019

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: 09/18/2019
• Device Model Number: G38491
• Device Catalogue Number: ZISV6-35-125-7-140-PTX
• Device Lot Number: C1557555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2019
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2019
• 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
• Date Report Sent to FDA: 09/03/2019