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

Catalog Number	PXB35-05-17-080
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/07/2018
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
The physician attempted to use a visipro with a 6f 65 cm non-medtronic sheath and a 0.035 non-medtronic guidewire to treat a 10-15mm fibrous and minimally calcified lesion with 50% stenosis in the proximal left subclavian artery of diameter 5 mm.It was reported that upon advancing the stent to the lesion site a discrepancy between the stent end and the balloon end markers was noticed.Due to the misalignment of markers and insecurity of stent the physician pulled the device as a single unit down with the intention of removing it but the stent became dislodged on the balloon delivery system and fully dislodged in the iliac artery the physician was unable to even perform ¿off-target¿ stent as there was not enough balloon inside the stent to attempt deployment.The physician accessed from the contralateral side to get up and over to successfully snare the dislodged stent with a non-medtronic snare.
Additional Manufacturer Narrative
Cine image review: two images was provided from the procedure.The first photo provided was a photo of the stent detached from the catheter.The stent was not expanded, which would indicate the stent was not deployed as intended.The photo shows bending of the struts at both ends of the stent.The stent shows damage but remains intact.No signs of portions of the stent fracturing off were identified from the photo.A cine image was provided shows the guidewire inserted the vessel.The introducer sheath or visi-pro catheter and/or stent could not be identified from the cine.Device evaluation: the visi pro was inspected and observed the stent was no loaded over the balloon.There were no signs of balloon expansion.The proximal and distal marker bands were inspected under microscope and identified the balloon areas where the stent was previously loaded.No damages to the balloon, catheter shaft, or manifold were noted.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: 8159328
• Report Number: 2183870-2018-00579
• Device Sequence Number: 19382647
• Product Code: NIO
• UDI-Device Identifier: 00643169787575
• UDI-Public: 00643169787575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/01/2019

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: 09/19/2021
• Device Catalogue Number: PXB35-05-17-080
• Device Lot Number: A710476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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: 70 YR
• Patient Weight: 93