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

Catalog Number EVD35-07-150-120

Device Problems Misfire (2532); Firing Problem (4011)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It is reported that during treatment of a 150mm lesion in the superficial femoral artery (sfa) the device partially deployed.No patient injury was reported.

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 LONG
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7717440
• MDR Text Key: 115356704
• Report Number: 2183870-2018-00392
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051474
• UDI-Public: 00821684051474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2021
• Device Catalogue Number: EVD35-07-150-120
• Device Lot Number: A584094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1