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

Catalog Number EVX35-06-150-120

Device Problem Malposition of Device (2616)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was using an everflex entrust stent to treat a lesion.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.It was reported that the stent was deployed in the unintended lesion.Another everflex stent was successfully deployed in the intended lesion.

Manufacturer Narrative

Device evaluation several kinks were noted in the catheter and that the red safety tab had been removed from the handle but not returned with the device.The kinks may have been formed post-procedure given how the device was packaged for return.Examination of the handle¿s safety tab cavity revealed that the pull cable was not visible within the handle; indicating that the pull cable was broken.A kink in the catheter was noted approximately 31.5cm from the distal tip of the catheter.A set of two kinks were noted at 151.8cm and 155.1cm from the distal tip of the catheter.The printed strain relief was removed to allow further examination of the handle by splitting it open along its seams.No deformation of the inner guidewire lumen was noted within the handle.No unusual wear marks were noted within the handle; which indicates that the pull cable was properly routed within the handle.The inner guidewire lumen was cut just distal of the proximal hub luer lock to allow further examination of the catheter.The blue strain relief and gold colored isolation sheath were removed by sliding them proximally over the inner guidewire lumen.A small portion of the pull cable remained bonded to the outer sheath.Backlighting of the outer sheath located the distal end of the outer sheath; indicating that no portion of the stent remained within the outer sheath.If information is provided in the future, a supplemental report will be issued.

Event Description

No further information available.

• 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: 8631097
• MDR Text Key: 145735830
• Report Number: 2183870-2019-00289
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Catalogue Number: EVX35-06-150-120
• Device Lot Number: A656684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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
• Patient Outcome(s): Required Intervention