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

Catalog Number	PXB35-09-37-080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the visi-pro balloon-expandable biliary stent system was received for evaluation.A proximal strut with radiopaque marker hoop was noted to be bent distally.Cine image review: a disk containing 43 series of cine images was received and reviewed.None of the cine series included cines of the damaged visi-pro stent.The series did include pre-dilatation of the targeted vessel anatomies and the implantation of three balloon expandable stents in the right common iliac.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to treat patient at the right, proximal common iliac artery using a visi-pro stent.Lesion type was calcified with moderate tortuosity and severe calcification.Artery diameter was 9 mm and lesion length was 30 mm.A 0.035" guidewire was used during procedure.It is reported that stent deformed in vivo during delivery through the vessel.Physician stated the lesion was highly calcified.Procedure was completed using a second visi-pro stent of the same size.No patient injury reported.
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: 6442871
• Report Number: 2183870-2017-00149
• Device Sequence Number: 976789
• Product Code: FGE
• UDI-Device Identifier: 00821684036587
• UDI-Public: 00821684036587
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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 Expiration Date: 10/25/2019
• Device Catalogue Number: PXB35-09-37-080
• Device Lot Number: A364977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 73