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

Model Number EVD35-06-150-120

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: a second device was returned for this event, and follow-up confirmed the device was related to this event.This everflex entrust device was received to the medtronic investigation lab for evaluation.The device was labelled as being associated with this complaint.The everflex entrust was returned inside the previously opened everflex entrust box and pouch which both indicated lot a840545.It was discovered a 0.014" guidewire was loaded and a non-medtronic introducer was returned.The deployment system was returned with a 0.014"" guidewire stuck loaded in the catheter.A non-medtronic sheath was returned with a suspected everflex stent protruding out from the distal end.The deployment system was inspected.It was observed the locking pin was removed and not included with the returned contents.The handle assembly showed inner assembly exposed between the right and the left handle assemblies.Approximately 22cm of the 0.014" gw was exposed outside of the distal end of the catheter shaft.A bend to the everflex entrust catheter shaft was noted at approximately 65cm from the distal tip.Direct light applied to the distal end of the catheter shaft found the stent was not loaded the catheter.The pusher was identified approximately 10cm from the distal tip of the catheter, which indicates the stent did not deploy as intended.The gw was unable to be removed from the deployment system due to encountered resistance.The handle assembly was cracked open.It was found the inner assembly was folded over itself and showed buckling.The pull cable detached from the silver outer bond.The area of the detachment shows the silver outer frayed out at the bond area which suggests exposure to excessive tensile force.The detached end of the pull cable remained intact.The non-medtronic introducer was inspected and observed a fractured stent was protruding out from the distal rim of the introducer by approximately 1cm.The tantalum markers at the end of the stent were not present, which indicates the stent fractured/broke off.The exposed stent showed biological material adhering to the struts.The exposed struts were bent in various directions.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used an everflex entrust with a non-medtronic 5fr sheath during treatment of a calcified lesion in the patient¿s mid superficial femoral artery (sfa).Moderate calcification and tortuosity are reported.Ifu was followed.The device was prepped without issue.Pre-dilation was performed using a pacific xtreme.Slight resistance was noted when introducing the catheter.The everflex entrust was not passed through a previously deployed stent.It is reported a break/fracture occurred at the mid segment of the stent during deployment.This occurred as the device was pulled hard, causing the separation/fracture.The fractured portion was left in the patient and the remainder removed as it remained on the stent shaft.The device was extracted successfully.The procedure was finished by inflating a pta balloon to nominal pressure of 8atm.Additional device received which aligns with the reported event.It is unknown if the initial device received may have been used during the procedure.

• 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 ; IE ; 091708734
• MDR Report Key: 9680427
• MDR Text Key: 206568445
• Report Number: 2183870-2020-00040
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: 00821684051399
• 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: Physician
• Type of Report: Initial
• Report Date: 02/07/2020

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: 05/31/2022
• Device Model Number: EVD35-06-150-120
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A840545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• 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