MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT

Model Number	G43858
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pro code: nio stent, iliac.(b)(4).
Event or Problem Description
According to the initial reporter, the barcode for an 8x80 stent that was used by the end user last week was apparently mis-labeled as the stent was in fact an 8-40 in length and not an 8-80.No additional procedures were needed.It was further reported that the stent was implanted and they did not realized it was the wrong size until they implanted it.Per the doctor the stent was deployed and then it was noticed that it was shorter.It does not seem likely that it compressed or shortened due to a kissing stent being deployed simultaneously that should have been shorter (60mm) and ended up looking longer.The stent was not long enough and two additional stents were required to achieve a satisfactory result.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10824029
• Report Number: 3005580113-2020-00443
• Device Sequence Number: 11490226
• Product Code: FGE
• UDI-Device Identifier: 10827002438580
• UDI-Public: (01)10827002438580(17)230615(10)C1735302
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 11/11/2020
• Report Date (Section F): 11/09/2020

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: 06/15/2023
• Device Model Number: G43858
• Device Catalogue Number: ZIV6-35-80-8-80
• Device Lot Number: C1735302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2020
• 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