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 Activation Problem (4042)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/14/2019

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 intended to use an everflex entrust stent to treat a moderately calcified, moderately tortuos, 80% stenotic lesion in the mid proximal superficial femoral artery(sfa).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.Pre-dilation was performed using a non-medtronic pta balloon.The everflex entrust device did not pass through a previously deployed stent however, resistance was encountered but no force applied during delivery of the device to the lesion.The thumbscrew was checked for securement prior to the procedure.The lock pin was removed prior to attempting to deploy the stent.It was reported that the physician was unable to deploy the stent, the guidewire is reported to have become stuck inside the device so both were removed together.Due to loss of access of the guidewire the procedure was ended at this point.The patient has since been sent for surgery due re-blockage of the artery as the stent was not implanted.

Manufacturer Narrative

Device evaluation: the everflex entrust was returned with the red lock pin was removed from the handle assembly.The everflex entrust was returned with the stent loaded the catheter with no signs of deployment.A bend of approximately 45 degrees to the catheter shaft approximately 4cm from the distal tip of the catheter was noted.A 0.0355" gw was loaded.Approximately 0.1cm of the guidewire was observed sticking out from the distal tip of the everflex entrust catheter shaft.The proximal end of the handle assembly showed the guidewire loaded inside the clear gw lumen luer.It should be noted the recommended guidewire size is 0.035" per product labeling.Functional testing: the loaded guidewire was attempted to be removed by pulling back and pushing forward on the gw.No movement was noted.The handle assembly was cracked open.It was discovered the pull cable had broke within the handle assembly approximately 14 cm proximal to the silver outer bond.The pull cable was frayed at both ends of the discovered separation, likely due to exposure to excessive tensile forces.The inner as inspected and observed buckling at three locations (4, 7, 10 cm) and along the inner from the proximal end of the silver outer.The thumb wheel with the pull cable attached was inspected.The distal end of the pull cable was frayed.Image review: the customer provided three photos.The first photo attached shows the device carton label which indicates lot a590900 and is consistent with the as reported lot number.The second and third photos provided are of the handle assembly with the red pull cable removed.No damage to the handle assembly were noted.The third photo was of the empty slot where the red pull cable was previously loaded.No damages to the visible internal components were visible.If information is provided in the future, a supplemental report will be issued.

• 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: 8508019
• MDR Text Key: 141726329
• Report Number: 2183870-2019-00170
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: EVX35-06-150-120
• Device Lot Number: A590900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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
• Patient Age: 72 YR