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

Catalog Number	EVD35-07-040-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.The entrust stent delivery system was received loaded on a 0.014¿ guidewire.The use of a guidewire smaller than 0.035¿ does not fully support the entrust delivery system.The everflex entrust sds was received with approximately half a longitudinal stent cell exposed and flowered.The handle¿s safety tab cavity was examined: the guidewire lumen was noted to be accordion folded.The accordion folding damage is consistent with a guidewire not fully supporting the entrust delivery system.A series of kinks were noted in the silver outer sheath of the entrust stent delivery system catheter.The kinks start approximately 4.5cm proximal of the distal tip and go to approximately 19.5cm proximal of the distal tip.The average distance between the kinks is approximately 0.5cm.The series of kinks damage is consistent with advancing the entrust delivery system against resistance.
Event or Problem Description
Physician intended to use an everflex self-expanding stent with entrust delivery system, using a 5 fr sheath and.014 guidewire for the treatment of a 35mm moderately tortuous, non-calcified plaque lesion in the right mid superficial femoral artery of diameter 7mm which exhibited 70% stenosis.Device ifu was followed and device prepped with no issues identified.It was reported that resistance was encountered when advancing the device/delivery to the lesion and excessive force was required.The stent was being deployed over a.014 guidewire, which was unsuccessful as the.014 guidewire became stuck on system, stent flared but would not deploy.The entire system, wire, and stent were removed with resistance, ultimately losing access.A second everflex entrust was used but stent was delivered over a.035 wire to successfully complete the procedure.The patient had no adverse events as a result of this.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6676147
• Report Number: 2183870-2017-00279
• Device Sequence Number: 13463677
• Product Code: NIP
• UDI-Device Identifier: 00821684051429
• UDI-Public: 00821684051429
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Followup
• Report Date (Section B): 06/01/2017

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: 03/28/2020
• Device Catalogue Number: EVD35-07-040-120
• Device Lot Number: A436787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 99