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

Catalog Number	EVD35-06-120-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the everflex entrust stent delivery system was received for evaluation.The entrust sds was received with inner guidewire lumen removed from the entrust sds.No ancillary devices or cines were provided for evaluation.The proximal end of the inner guidewire was examined under magnification and a manufacturing cut edge, a sanded surface and a lack of adequate amount of adhesive residue was observed.The entrust sds was examined.The catheter of the sds exhibited several kinks.The entrust sds was received with the red safety tab and tube removed from the handle.The red safety tab and tube were not returned with the sds.The handle¿s safety tab cavity was examined: the sds silver outer sheath was visible within the cavity.The handle was opened along its seams.The pull cable was properly routed within the handle and it had pulled the silver outer sheath around the pulley in the handle.The handle¿s luer lock was still within the handle.Examination of the luer lock revealed an insufficient amount of adhesive in the bond between the inner guidewire lumen and the handle luer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using one everflex entrust device to treat a slightly calcified and slightly tortuous mid sfa lesion (5 x 100 mm) exhibiting 80% stenosis.A non-medtronic sheath ( 6 cook raabe) and guidewire ( 035 rosen) was used.Embolic protection was not used.The device was inspected prior to use with no issues noted.The ifu was followed during the procedure.The lesion was predilated.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force was used.It was reported that after stent deployment, the catheter handle detached from the catheter outside the sheath.The physician walked out the device by hand, the catheter was able to be removed over the wire with what was out of the sheath.Difficulty was experienced while removing the device.The catheter did not catch on the stent during withdrawal.No intervention was needed and 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: 7637547
• Report Number: 2183870-2018-00350
• Device Sequence Number: 19319241
• Product Code: NIP
• UDI-Device Identifier: 00821684051382
• UDI-Public: 00821684051382
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/26/2018

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: 02/28/2019
• Device Catalogue Number: EVD35-06-120-120
• Device Lot Number: A234781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1