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

Catalog Number EVX35-08-040-080

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An everflex entrust was used for treatment for a lesion in the patient¿ superficial femoral artery (sfa).This stent was to be implanted following recanalization for the previously closed pelvic flow path using a 5.5fr sheath from left to right in the external iliac.Previous everflex entrust was implanted in the iliac artery, and plan was to place this everflex entrust just reaching above the bifurcation (2 mm).Ifu was followed and the device was prepped without issues.It is reported on the way to the lesion resistance was experienced but physician was able to continue advancing the device.This led to the stent self-deploying in the aortic bifurcation.This was prior to releasing the red lock-pin.The stent was unfolded in the external iliac artery under fluoroscopy.The lock-pin remained in place and was pushed back a bit resulting in jutting from left to right in the external iliac.Through use of mechanical aids, the stent was stretched into the distal aorta where it is protruding 18-19 mm but the pelvic flow path is not affected.Patient will undergo stent explanation.Procedure date to be confirmed.

Manufacturer Narrative

Product analysis: the everflex entrust stent delivery system, (sds), was received for evaluation.No ancillary devices from the procedure were received for evaluation.The entrust sds was received with a kink near its distal end.The kink most likely happened post procedure given how the device was packaged for return.Backlighting of the distal end of the sds outer sheath revealed that the stent was not within the sds.Backlighting also revealed the location of the distal end of the inner guidewire lumen/pusher.The distal end of the inner guidewire lumen/pusher was marked on the exterior of the outer sheath.The distal end of the inner guidewire lumen/pusher is approximately 40mm proximal of the distal end of the outer sheath.The distal end of the inner guidewire lumen/pusher is at its position when it was released from manufacturing.The entire length of the sds catheter was examined.A second kink was noted approximately 77.3cm from the distal tip of the outer sheath at the distal tip of blue isolation sheath/strain relief.The kink most likely happened post-procedure given how the device was packaged for return.The entrust sds was received with the red safety tab still engaged with deployment handle.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: 9070038
• MDR Text Key: 161776782
• Report Number: 2183870-2019-00452
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: EVX35-08-040-080
• Device Lot Number: A780261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2019
• 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: 72 YR