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

Catalog Number	AB35W06030135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2018
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
It was reported that the physician used an evercross device during treatment of a moderately calcified lesion in the mid left superficial femoral artery (sfa).The lesion was reported to exhibit 90% stenosis and the vessel was reported to exhibit no tortuosity.The device was prepped as per ifu without issue.No embolic protection was used and the device did not pass through a previously deployed stent.No resistance was encountered during advancement of the device.A non-mdt inflation device was used.It is reported that a balloon burst occurred during balloon inflation at a pressure of 8atms on the second inflation.There were no balloon fragments.A 6x40 everflex stent was then deployed to cover the lesion.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: 7391422
• Report Number: 2183870-2018-00201
• Device Sequence Number: 1144194
• Product Code: LIT
• UDI-Device Identifier: 00821684061596
• UDI-Public: 00821684061596
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/03/2018

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: 12/15/2018
• Device Catalogue Number: AB35W06030135
• Device Lot Number: A202008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 04/03/2018
• 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: 84 YR
• Patient Weight: 89