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

Catalog Number	EVD35-06-150-150
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use an everflex entrust to treat a calcified plaque chronic total occlusion (cto) lesion in the distal right superficial femoral artery (sfa).Moderate tortuosity was reported.A 6fr non medtronic sheath and a 0.014 x non medtronic guidewire was used.No embolic protection was used.The device was prepped per ifu with no issues.There was no damage to the device packaging or the device when removing from the hoop/tray.There was no damage to the deployment mechanism or handle prior to deployment.The thumbscrew/lock pin was checked for securement prior to the procedure and the lock pin removed when the physician was ready to deploy the stent.The lesion was predilated with a 4 x 150 device.The entrust did not pass through a previously deployed stent, no resistance was encountered and no excessive force used.It was reported that the stent was deployed about half way when the thumb switch started to turn without any further deployment.The handle was broken open and the stent deployed manually.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: the everflex entrust stent delivery system, (sds), was received for evaluation within a sealed tyvek pouch, within a nested series of sealed plastic biohazard pouches, and loosely coiled within a sealed sterilization pouch.No ancillary devices from the procedure were received for evaluation.The entrust stent delivery system was received with the deployment handle separated from the catheter, and the handle disassembled.The pull cable was wrapped around the thumbwheel.The distal tip of the handle assembly was examined for unusual wear/witness marks: no unusual wear/witness marks were noted indicating that the pull cable was properly routed through the handle.The inner guidewire lumen was position back into the handle and a series of kinks in the inner guidewire lumen aligned with handle¿s safety tab cavity.The kinks most likely happened during the deployment attempt and were formed by an undersized guidewire not fully supporting the inner guidewire lumen.The exposed proximal end of the outer sheath was examined; and the pull cable bond was broken.The distal end of the outer sheath was examined; the distal end was oval in shape.It is not known when the distal end of the outer sheath was deformed into the oval shape.The deformation may have happened post-procedure given how the device was packaged for return.The distal end of the outer sheath was examined using backlighting to determine if a stent remained in the system and to locate the distal end of the inner guidewire lumen/pusher.The distal end of the inner guidewire lumen/pusher is approximately 22.8cm from the distal tip of the outer sheath.Since the entrust is to deliver a 150mm length stent the location of the distal end of inner guidewire lumen/pusher indicates that the outer sheath has been moved distally from the handle after the pull cable separated from the outer sheath.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
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8324860
• Report Number: 2183870-2019-00067
• Device Sequence Number: 16573424
• Product Code: NIP
• UDI-Device Identifier: 00821684051634
• UDI-Public: 00821684051634
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2020
• Device Catalogue Number: EVD35-06-150-150
• Device Lot Number: A508977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 145