MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	EVD35-06-150-150
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used an everflex entrust with a 7f 45cm non-medtronic sheath during treatment of a calcified lesion in the patient¿s mid superficial femoral artery (sfa).Slight tortuosity and moderate calcification are reported.No damage noted to packaging or issue noted when removing device from packaging.Ifu was followed and the device was prepped without issue.Pre-dilation was not performed.The thumbscrew/lock-pin checked for securement prior to procedure.No resistance was encountered when advancing the device.The lock-pin was removed when physician was ready to deploy the stent.The physician attempted to deploy the stent, but deployment issues were experienced.The physician had to undo the handle of the stent delivery system and pull the sheath in order to fully deploy the stent.The stent was successfully deployed in the target ares.No further treatment was required.No patient injury reported.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8127971
• Report Number: 2183870-2018-00560
• Device Sequence Number: 13847779
• Product Code: NIP
• UDI-Device Identifier: 00821684051634
• UDI-Public: 00821684051634
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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: 08/10/2021
• Device Catalogue Number: EVD35-06-150-150
• Device Lot Number: A690941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1