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

Catalog Number	EVD35-07-150-150
Medical Device Problem Codes	Stretched (1601); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
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 was attempted to use an everflex entrust in the proximal left superficial femoral artery (sfa) to treat a 120mm moderately calcified fibrous soft tissue chronic total occlusion (cto).No patient anatomy abnormalities were reported.Little tortuosity was reported in the 7mm artery.A 6fr non medtronic sheath and a non medtronic guidewire was used in the procedure.No embolic protection was used.Pre-dilation was completed with a 4mm and 5mm device.There was no damage observed to the device during removal from packaging.The device was prepped as per ifu with no issues identified and there was no damage to the deployment mechanism or handle prior to use.The device passed through a previously deployed stent.No resistance was encountered and no excessive force used.It was reported that deployment issues were encountered, the stent partially deployed in the patient and stent deformation occurred in vivo during positioning / deployment.The thumb wheel stopped working and the stent could not be completely deployed by unwinding the thumb wheel further.The stent was manually deployed and 10-20mm stent elongation was observed.The procedure was completed using post dilation but some recoil (approx.10-15%) remained.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: a non-medtronic guidewire of diameter 0.035¿ was used in the procedure.Device evaluation: the everflex entrust was removed from the pouch and inspected.The red safety pin was not loaded the handle assembly.A kink to the catheter shaft was observed distal to the blue strain relief.A kink to the catheter shaft was noted approximately 8cm from the distal tip.No other damages to the deployment system were noted.Direct light was applied to the distal end of the catheter shaft.The pusher was approximately 3.5cm from the distal rim of the catheter shaft.No stent was present.Functional testing: the thumb wheel of the handle assembly was rotated.No resistance was encountered, and the pusher did not advance.The handle assembly was cracked open to inspect the internal components.The proximal end of the silver outer was buckled for approximately 0.5cm proximal to the blue strain relief.The pull cable was detached from the proximal end of the silver outer.The pull cable was frayed at the end and the silver outer.The proximal end of the silver outer where the pull cable was previously attached showed damage consistent with exposer to excessive tensile forces.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: 8247846
• Report Number: 2183870-2019-00020
• Device Sequence Number: 19403032
• Product Code: NIP
• UDI-Device Identifier: 00821684051719
• UDI-Public: 00821684051719
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/01/2019

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: 08/09/2021
• Device Catalogue Number: EVD35-07-150-150
• Device Lot Number: A690150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR