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

Catalog Number	PXB35-08-17-135
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician employed the use of a visi pro stent with a 6fr sheath and.035 guidewire for treatment of a 13mm moderately calcified, moderately tortuous plaque lesion in proximal location in the left common iliac artery of diameter 6mm which exhibited >60% stenosis.The device was prepped as per ifu with no issues identified.The lesion was not pre-dilated.The device passed through a previously deployed stent.When advancing the device, the physician encountered resistance.It was reported that during delivery of the stent, it came off in the sheath (from the left contralateral) while attempting to stent the right common iliac.The sheath was pulled back and the balloon was able to retrieve the stent but it had migrated out of the sheath.The stent was deployed in the left common iliac and on deployment, vessel dissection occurred.An everflex 6x60 stent was deployed to cover the dissection.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6665575
• Report Number: 2183870-2017-00273
• Device Sequence Number: 1882689
• Product Code: FGE
• UDI-Device Identifier: 00821684036471
• UDI-Public: 00821684036471
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: 07/28/2019
• Device Catalogue Number: PXB35-08-17-135
• Device Lot Number: A318248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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