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

Catalog Number	EVD35-07-060-120
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
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
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use an everflex entrust with a 7f sheath and 035 guidewire for treatment of an 80mm slightly tortuous, slightly calcified lesion in distal location in the common iliac artery of diameter 7mm which exhibited 60% stenosis.Lesion was pre-dilated using a 6x80 pre-dilation device.Embolic protection was not used.The device was prepped as per ifu.Thumbscrew/ lock-pin was checked for securement prior to procedure.There was no resistance encountered during advancement or excessive force required.The device passed through a previously deployed stent.The lock-pin was removed prior to deployment.The stent deployed but "jumped" leaving part of the dissection uncovered; a second stent (balloon mounted) was then deployed to successfully complete the procedure.Abnormalities reported in relation to patient anatomy - dissection.The dissection occurred during the pre-dilation process - stent was not responsible.
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: 6680249
• Report Number: 2183870-2017-00282
• Device Sequence Number: 1539243
• Product Code: NIP
• UDI-Device Identifier: 00821684051436
• UDI-Public: 00821684051436
• 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
• Device Implanted Year: 2017
• 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: 02/10/2020
• Device Catalogue Number: EVD35-07-060-120
• Device Lot Number: A413326
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86