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 Codes	Inaccurate Delivery (2339); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
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 device with a 6f sheath and non-mdt.035 guidewire for treatment of a fistula (concentric with no calcium) in a venous axillary vessel.Ifu followed and device prepped without issue.No embolic protection was used the device did not pass through a previously deployed stent.No resistance was encountered when advancing the device no excessive force was used.When the physician attempted to deploy the stent, it jumped forward and was reported to have landed midway through the lesion.The physician stated that wires were sticking out of the area on the entrust delivery handle when he removed the red safety pin.He did not notice these wires until after the stent had been deployed and looked at the delivery system.The physician opted not to place a second stent as there was no flow disruption.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: 7577135
• Report Number: 2183870-2018-00318
• Device Sequence Number: 11391724
• Product Code: NIP
• UDI-Device Identifier: 00821684051276
• UDI-Public: 00821684051276
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/07/2018

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: 03/13/2021
• Device Catalogue Number: EVD35-08-040-080
• Device Lot Number: A612862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR