MAUDE Adverse Event Report: COOK INC ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G50164
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: a 0.018 boston scientific v-18 hydrophilic wire; 1.7 spectranetics laser; bard.018 ultraverse 2.5mmx300mm balloon; 5x2 cook.035 balloon.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that while the physician was attempting to place the stent he encountered tracking difficulty between two previously placed stents.The target lesion was the superficial femoral artery.Two g50164 stents had already been placed in the patient¿s superficial femoral artery- one in the proximal portion and one in the most distal portion.A third device was to be placed in the middle section of the superficial femoral artery connecting the other two stents, but the stent would not track through the other stents.It was assumed it was due to the transition between the stent catheter and the 0.018 boston scientific v-18 hydrophilic wire that was in use at that time.The physician then treated the patient below the knee with a balloon and laser, then changed to a new wire and attempted to place the stent once more, but it was difficult to pass through the first stent and would not overlap with the second stent.The physician then attempted to expand the stents with a balloon, but this was unsuccessful.The device was removed and examined, revealing that the tip of the stent placement catheter was jagged.A new device was used, and the procedure was successfully completed without further incident.There were no injuries or additional procedures.

• Brand Name: ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7273932
• Report Number: 1820334-2018-00502
• Device Sequence Number: 1917841
• Product Code: FGE
• UDI-Device Identifier: 10827002501642
• UDI-Public: (01)10827002501642(17)180910(10)6227170
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G50164
• Device Catalogue Number: ZIB6-35-125-5-140
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR