MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number PRB35-08-120-080

Device Problem Fracture (1260)

Patient Problems Extravasation (1842); Perforation (2001)

Event Date 02/05/2016

Event Type  Injury  

Event Description

The protégé everflex stent was implanted (b)(6) 2016 in the left iliac artery and was post-dilated with a 7x40 evercross balloon.An inpact admiral balloon was also used to secure the everflex stent to the artery wall.During a follow up procedure on (b)(6) 2016, there was an extravasation of contrast in the distal aspect of the left external iliac.This is consistent with a perforation with a stent fracture as the cause.An 8x50mm covered stent was deployed, sealing the perforation.

Event Description

Evaluation summary: from a review of the cine images, an area of uneven stent expansion was noted.The area exhibits stent cell elongation and stent off-set.Review of the images support the report of extravasation of contrast from the stented portion of the distal left external iliac artery.There was a slight out-pouching of the stent in that location.This is most likely due to a stent fracture.The quality and clarity of the cines provided did not clearly show stent fracture in the deployed stent.The cines show stent cell elongation, stent cell off-set and uneven stent expansion.

Manufacturer Narrative

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

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT 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: mary haufek ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5571617
• MDR Text Key: 42491475
• Report Number: 2183870-2016-00316
• Device Sequence Number: 1
• Product Code: NIP
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2016
• Device Model Number: PRB35-08-120-080
• Device Catalogue Number: PRB35-08-120-080
• Device Lot Number: 9774681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00062 YR