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

Catalog Number	EVD35-08-040-080
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2018
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 intended to use an everflex entrust to treat a 40mm calcified cto (chronic total occlusion - 100%) in the patient¿s distal right common iliac artery.The vessel diameter was reported to be 7mm.A non-medtronic 6f sheath and a non-medtronic 0.035 wire were used.The lesion was reported to be of moderate tortuosity and calcification.The ifu was followed and the device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to procedure.Embolic protection was not used.Pre-dilation was carried out using an 8mm pre-dilation device.It was reported that deployment issues occurred when the red safety was pulled prior to deployment - it became caught on a wire and the stent deployed on its own.The stent was reported to have deployed in the correct area.
Additional Manufacturer Narrative
Additional information: there was no patient injury reported.Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.No ancillary devices from the procedure were received for evaluation.The returned entrust sds showed the red safety tab and tube were not fully removed.The pull cable was found to wrapped around the red safety tube and inner guidewire lumen.This would have occured due to multiple rotations of the stent delivery system prior to attempts to deploy the stent.If information is provided in the future, a supplemental report will be issued.
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: 7734263
• Report Number: 2183870-2018-00403
• Device Sequence Number: 1050240
• Product Code: NIP
• UDI-Device Identifier: 00821684051276
• UDI-Public: 00821684051276
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 10/10/2018

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: 03/28/2021
• Device Catalogue Number: EVD35-08-040-080
• Device Lot Number: A621006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/12/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/10/2018
• 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