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

Catalog Number	EVD35-08-150-150
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the entrust stent delivery system, (sds), was received for evaluation.The entrust sds was received without the red safety tab and tube.Approximately 4.9cm of the 150mm stent was received exposed and flowered.The entrust sds was received with the blue strain relief/isolation sheath and gold colored isolation sheath separated from the sds handle.The proximal end of the silver colored outer sheath showed that the pull cable to outer sheath has been broken.The sds handle safety tab cavity was examined: the inner guidewire lumen was straight & exhibiting no abnormality or deformity and the pull cable was spiral wrapped around the inner guidewire lumen.This spiral wrapping of the handle indicated the handle was torqued in multiple rotations.This multiple torqueing would lead to the failure of the pull cable to outer sheath bond.The overall length of the sds was examined: several kinks along its length were noted.The overall length of the sds is approximately 177.2cm when it should be 150cm.The extra length would be consistent with the failed pull cable to outer sheath bond.The sds handle was split opened along its seam: the pull cable was wrapped around the handle pulley and thumb wheel.Examination of the 2 photographic images did not give any extra information or any contradictory information to that received in the examination of the actual device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use an everflex entrust device with a non-mdt 7f sheath and a non-mdt 0.035" guidewire for the treatment of a severely calcified lesion in the proximal/mid/distal right external/common iliac artery.The lesion was 120mm in length and described as 100% stenosed, pre-dilation, and 80% stenosed, post dilation.Pre-dilation was carried out using the following devices: nanocross 3mmx60mm, nanocross 4mmx150mm & an evercross 6mmx80mm.The vessel was 8mm in diameter.The device was prepped as per ifu without issue.No embolic protection was used.It was reported the device was advanced to the desired location in the right external iliac (target lesion) passing through a previously deployed stent without resistance.The physician then pulled back on the delivery system until no slack was noted.The safety locking pin was removed.The physician then checked the slack on the stent again and the silver retractable outer sheath caught onto the gold isolation sheath and wrapped around itself.The stent and the delivery system, as a whole unit, was then removed.Upon removal of the stent it was noted that the stent had become partially deployed.Protégé everflex stents (8mm x 100mm and 8mm x 40mm) were successfully deployed to complete the procedure.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: 7425560
• Report Number: 2183870-2018-00228
• Device Sequence Number: 127850
• Product Code: NIP
• UDI-Device Identifier: 00821684051795
• UDI-Public: 00821684051795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/12/2018

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: 10/26/2018
• Device Catalogue Number: EVD35-08-150-150
• Device Lot Number: A179384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 74