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

Catalog Number	EVD35-06-150-080
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.No ancillary devices from the procedure were received.The sds was received with the red safety tab and safety tube removed from the handle.Neither the red safety tab nor safety tube was received for evaluation.The sds safety tab cavity in the handle was examined: no abnormality was noted in the inner guidewire lumen and the pull cable was not visible in the cavity.The returned entrust sds exhibited erosion of the handle material by the pull cable being improperly routed within the handle halves.Outer sheath advancement was stopped when the pull cable entered an opening in the handle cavity.The pull cable to outer sheath bond area was pulled 90° from the direction of travel.The pull cable separated at this point.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the everflex entrust, with a non-medtronic 6fr sheath and a non-medtronic.018 guidewire to treat a plaque lesion with little calcification in the mid superficial femoral artery.The artery diameter and lesion length were reported to 5.5m <(>&<)> 150mm, respectively.It was reported that the physician had successfully placed a 6x150x150 distal to the lesion.As he was started to place this everflex entrust stent at the lesion, it deployed about 80% of the stent and then the wheel became stuck and would not rotate.He pressed hard to get it to deploy, and then the handle broke.Once he started to pull the catheter back, the stent fully deployed successfully.No patient injury was 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: 7955360
• Report Number: 2183870-2018-00464
• Device Sequence Number: 10998281
• Product Code: NIP
• UDI-Device Identifier: 00821684051184
• UDI-Public: 00821684051184
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/11/2018

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: 03/15/2020
• Device Catalogue Number: EVD35-06-150-080
• Device Lot Number: A430159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1