MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PXB35-07-17-080
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the visi-pro balloon-expandable biliary stent system was received for evaluation.No ancillary devices or cine images from the procedure were received.The visi-pro delivery dilatation catheter was received with the balloon chamber in a post inflated state.Witness marks from the crimped stent could be seen on the post inflated balloon chamber material.Clear fluid was observed within the balloon chamber and sanguine residue was noted on the exterior of the balloon chamber.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a visi pro device with a non-mdt 7fr 55cm sheath and a non-mdt.035 x 260cm angled guidewire to treat an 80% calcified and stenosed left proximal subclavian artery.Moderate tortuosity was reported.The ifu was followed and the device was prepped without issue.The lesion was not pre-dilated.The device did not pass through a previously deployed stent and no embolic protection was used.The right groin was utilized with a 7fr sheath and.035x260 guidewire.The stenosis was not able to be crossed with the visi pro device.Upon removing the stent from the subclavian the stent became dislodged at the distal end of the sheath and was free floating in the artery, while still remaining on the wire.The physician was able to carefully advance a.035 trailblazer across the undeployed stent and exchanged the wire for a non-mdt.035"x260 wire.An evercross 7x20 balloon was then advanced into the undeployed stent.The stent was nudged into place and the evercross was used to successfully redeploy the stent at 12 atm at the left subclavian stenosis.No adverse effect to the patient was reported and he was reported to have been sent to the floor in a stable condition.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7573403
• Report Number: 2183870-2018-00311
• Device Sequence Number: 2221513
• Product Code: FGE
• UDI-Device Identifier: 00821684036389
• UDI-Public: 00821684036389
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

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: 09/12/2019
• Device Catalogue Number: PXB35-07-17-080
• Device Lot Number: A342080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/06/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 84