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

Catalog Number EVX35-05-080-120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use an everflex entrust to treat a moderately calcified lesion in the distal superficial femoral artery( sfa).The ifu was followed and the device was prepped without issue.No resistance was encountered when advancing the device nor was excessive force used.It was reported that deployment issues were experienced and the device partially deployed.The procedure was completed using another everflex stent.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 STANDARD
• 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: 8115520
• MDR Text Key: 128759921
• Report Number: 2183870-2018-00547
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2019
• Device Catalogue Number: EVX35-05-080-120
• Device Lot Number: A242599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 04/16/2019
• Date Device Manufactured: 03/12/2016
• 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