MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB35W08040080
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.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7085877
• Report Number: 2183870-2017-00543
• Device Sequence Number: 11042518
• Product Code: LIT
• UDI-Device Identifier: 00821684062043
• UDI-Public: 00821684062043
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• 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
• 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: 04/11/2020
• Device Catalogue Number: AB35W08040080
• Device Lot Number: A443427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial 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