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

Catalog Number	PXB35-08-27-135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use a visi-pro balloon-expandable stent to treat a 20 cm severely calcified lesion in the left proximal common iliac artery.The vessel had little tortuosity and the lesion had 90% stenosis.The artery diameter was 7.67mm.The procedure used a 6 fr non-medtronic sheath and a 0.035" non-medtronic guidewire.The visi-pro was prepped as per the ifu with no issues identified.The vessel was pre-dilated using an 4x4x40 evercross pta balloon without difficulty.The device did not pass through a previously deployed stent.During the first inflation at 8 atms, the stent balloon burst longitudinally.The vessel was successfully stented using the visi-pro balloon-expandable stent, despite rupture of the stent balloon.The fractured balloon was removed, and no intervention was required to remove any balloon particulates.The lesion was then post-dilated with the 8x40 evercross pta balloon.There was rupture with this balloon as well during inflation.The balloon was removed, and no intervention was required to remove balloon fragments.The procedure was completed using a non-medtronic balloon.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the visi-pro device was inspected and found a radial tear on the balloon.The distal portion of the balloon was pushed distally.Ap proximately 2.5 cm of the blue inner was exposed between the fractured ends of the balloon.Traces of blood were noted within the manifold, balloon, and the blue inner/guidewire tubing.Both marker bands were identified and accounted for on the blue guidewire tubing.A kink to the catheter shaft was observed approximately 37cm from the distal tip.The working length of the returned catheter was approximately 138cm.The balloon length of the proximal portion was approximately 3cm.Product labeling shows the balloon length as 3cm.The distance between the marker bands was approximately 6cm.According to the product labeling the distance between marker bands is 3cm.Portions of the balloon were not returned.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: 7085875
• Report Number: 2183870-2017-00542
• Device Sequence Number: 19239820
• Product Code: NIO
• UDI-Device Identifier: 00821684036495
• UDI-Public: 00821684036495
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• 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): 12/06/2017

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: 04/16/2020
• Device Catalogue Number: PXB35-08-27-135
• Device Lot Number: A445684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 78