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

Catalog Number	EVD35-06-080-120
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the everflex entrust was inspected and observed a 0.014" guidewire loaded within the catheter.The distal end of the catheter showed a curve, but no creases at the distal end.A kink was noted approximately 113cm from the distal tip.The blue isolation sheath was attached to the handle assembly as intended.It should be noted, the stent has not been deployed and is currently loaded the catheter.The rotating wheel on the handle assembly was attempted to be turned, but resistance was encountered immediately.It was discovered the inner assembly within the handle assembly was buckled and showed consecutive bends which exceeded 90 degrees.
Event or Problem Description
Physician intended to use an everflex self-expanding stent with entrust delivery system with for the treatment of a slightly calcified and tortuous plaque lesion in the proximal location in the right mid superficial femoral artery.Lesion exhibited 70% stenosis.Device ifu was followed.Device prepped without issue.A non-medtronic 7 fr sheath was used.The physician removed the lock-pin after crossing the lesion and right before deployment.It was reported that there was difficulty encountered in deploying the stent ¿ the stent would not deploy.The physician mentioned that it appeared that the tantalum marker dots got caught up on the stent shaft and would not deploy.The distal marker dots would not deploy/come out of shaft of stent.Physician tried a second everflex entrust stent, but the same thing happened again.A different model stent (evd35-06-100-120) was then used to complete the procedure without further issue.No patient injury was reported.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6950295
• Report Number: 2183870-2017-00449
• Device Sequence Number: 109129
• Product Code: NIP
• UDI-Device Identifier: 00821684051368
• UDI-Public: 00821684051368
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• 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): 09/15/2017

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: 04/30/2020
• Device Catalogue Number: EVD35-06-080-120
• Device Lot Number: A453075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1