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

Catalog Number EVR35-08-040-120

Device Problem Detachment of Device or Device Component (2907)

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 plaque non calcified, non tortuous lesion in the mid right common iliac artery.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.No embolic protection was used.The device did pass through a previously deployed stent and resistance was encountered but no excessive force applied during delivery of the device to the lesion.It was reported that the catheter became caught on the stent struts in situ.The device was pulled back out of the patient.The deployed stent was bent inwards.When the catheter was removed it was noticed that the tip was missing.A non-medtronic stent was deployed to cage the tip.There was no patient injury reported.

Manufacturer Narrative

The physician was unable to locate the detached tip, it was thought that the tip was caged to the vessel wall.The patient is reported to be doing well.No follow up procedure planned.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation the everflex entrust stent delivery system, (sds), was received for evaluation within a white corrugated paper box, within a yellow plastic biohazard pouch, and loosely coiled within a plastic zippered pouch.No ancillary devices, cine images, or photographs from the procedure were received for evaluation.The entrust sds was received with the inner guidewire lumen protruding from the distal end of the sds outer sheath.The distal tip of the inner guidewire lumen is intact: no signs of detachment.The distal tip of the sds outer sheath is intact: no signs of detachment.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: 8623181
• MDR Text Key: 145478863
• Report Number: 2183870-2019-00275
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Catalogue Number: EVR35-08-040-120
• Device Lot Number: A321882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR