MAUDE Adverse Event Report: COOK INC ZILVER 635 VASCULAR SELF-EXPANDING STENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G43861
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A g52359-pta5-35-80-8-4.0 was used to pre dilate during stent placement.The g43861-ziv6-35-80-9-40 was placed successfully with no issues.During post dilating the stented area, the g52359-pta5-35-80-8-4.0 ruptured.The user removed the sheath and the balloon as a unit.During removal, the balloon caught on the stent, inverted it and balled it up.The tip of the balloon became stuck on the stent and detached.The detached balloon tip and damaged stent were sewn to the arterial wall to await removal surgery.The stent will be replaced as the patient is a dialysis patient and relies on this stent as a lifeline.Further information provided states: patient got infected and had to have an explant of the balloon part and stent.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10120248
• Report Number: 3005580113-2020-00374
• Device Sequence Number: 14319669
• Product Code: MIH
• UDI-Device Identifier: 10827002438610
• UDI-Public: (01)10827002438610(17)201113(10)C1419563
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/04/2020
• Report Date (Section F): 06/04/2020

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 Model Number: G43861
• Device Catalogue Number: ZIV6-35-80-9-40
• Device Lot Number: C1419563
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2020
• 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