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

Catalog Number	EVD35-07-060-150
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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
It was reported that the physician used an everflex entrust with a 6f non-mdt sheath and a non-mdt 260 guidewire for treatment of a 60mm moderately calcified lesion in the mid right superficial femoral artery(sfa) of diameter 6mm.The lesion was reported to exhibit 90% stenosis severe tortuosity.The ifu was followed and the device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to deployment.The lesion was pre-dilated using a 6x40 evercross pta balloon.Resistance was encountered when advancing the device.It was reported the physician attempted to drive the stent through the sheath it wouldn¿t go past aortic bifurcation where kissing stents were located.Upon removing the device from the patient, a few mm of the stent was seen to have partially deployed on tip of catheter outside of the sheath.A new everflex entrust was used to complete the procedure.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: 7573165
• Report Number: 2183870-2018-00310
• Device Sequence Number: 209739
• Product Code: NIP
• UDI-Device Identifier: 00821684051672
• UDI-Public: 00821684051672
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/06/2018

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: 08/10/2020
• Device Catalogue Number: EVD35-07-060-150
• Device Lot Number: A506583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 100