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

Model Number G43861

Device Problem Material Separation (1562)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 05/14/2020

Event Type  Injury  

Event 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
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10120248
• MDR Text Key: 195625499
• Report Number: 3005580113-2020-00374
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002438610
• UDI-Public: (01)10827002438610(17)201113(10)C1419563
• 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: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2020
• 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