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

Catalog Number EVX35-06-040-080

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Event Description

Physician was attempting to deploy an everflex self-expanding peripheral stent with entrust delivery system.It was reported that the stent was deployed in an unintended location.It was reported the stent was deployed with safety tab still in place.No patient injury reported for this event.

Manufacturer Narrative

The everflex entrust stent delivery system, (sds) was received for evaluation loose within a sealed plastic sterilization pouch.No ancillary devices or cine images from the procedure were received for evaluation.While the entrust sds was still in the sterilization pouch it was noted that the stent was pre-deployed, the catheter was kinked in two places, and that the red safety tab was still engaged with the sds handle.The kinks in the catheter may have happened post-procedure given how the device was packaged for return.Approximately 1.9 cm of the stent is exposed.Back lighting was used to locate the proximal end of the stent and the distal end of the push rod/guidewire lumen of the sds.The distance between the stent and the push rod is approximately equal length of the stent exposed.All components of the stent are accounted for.All components of the sds are accounted for.Given the pristine condition of the stent and that only part of the stent is pre-deployed; the stent pre-deployment happened prior to sds entering the hemostatic valve of the introducer sheath.Since the stent is pulled away from the push rod/guidewire lumen approximately the same length as the amount of stent exposed the most likely cause is interaction of the stent and guidewire during loading of the sds onto the guidewire.A good faith effort will be made to obtain the applicable information relevant to the report.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: 6474376
• MDR Text Key: 72570693
• Report Number: 2183870-2017-00158
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/12/2017

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: 10/20/2019
• Device Catalogue Number: EVX35-06-040-080
• Device Lot Number: A363027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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