MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; STENT, ILIAC

Catalog Number	PXB35-08-37-135
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a visi pro balloon expandable stent system with a 6fr sheath during treatment of a 30mm calcified lesion in the patient¿s mid common iliac artery of diameter 8mm.Moderate tortuosity and calcification are reported.Lesion exhibited 80% stenosis.Ifu was followed.Device prepped without issue.Resistance was encountered during advancement of the stent system.It is reported that stent dislodgement occurred during removal following failed delivery.The sheath was upsized, and a snare was used to remove the dislodged stent.Patient to be scheduled for an endarterectomy and iliac stent will be placed at that time.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a non-medtronic 0.035 guidewire was used.Severe difficulty was experienced during advancement.While in the process of advancing the device to the target area, the stent became caught on calcium which stripped the stent off the balloon while crossing the aortic arch prior to reaching the target lesion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8905296
• Report Number: 2183870-2019-00405
• Device Sequence Number: 19470079
• Product Code: NIO
• UDI-Device Identifier: 00821684036518
• UDI-Public: 00821684036518
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• 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,Followup,Followup
• Report Date (Section B): 11/01/2019

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: 08/05/2021
• Device Catalogue Number: PXB35-08-37-135
• Device Lot Number: A687728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 10/31/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 08/22/2019; 11/01/2019
• 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: 67 YR
• Patient Weight: 81