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	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cine image analysis: two photographic images of cine images were provided.The two photographic images are identical in content with the only difference being the amount of image contrast.The images are of the everflex stent implanted in the patient¿s mid superficial femoral artery.The everflex stent exhibits major elongation.The distal radiopaque end of the guidewire is visible in both images.The distal end of the guidewire is not near either end of the everflex stent.The core wire of the guidewire is visible running through the middle of the deployed elongated everflex stent.Device analysis: the everflex entrust stent delivery system was received for evaluation.The entrust sds, (0.035¿ guidewire compatible), was received loaded on a 0.014¿ compatible guidewire.The guidewire was locked up within the entrust sds.The entrust sds handle safety tab cavity was examined: the inner guidewire lumen was kinked within the cavity.The distal end of the sds silver colored outer sheath was back lighted to determine the location of the distal end of the inner guidewire lumen/pusher.The distal end of the inner guidewire lumen/pusher was approximately 7.5cm from the distal end of the silver colored outer sheath.The sds handle¿s printed strain relief was skived to allow examination of the interior of the handle.The pull cable was received separated from the outer sheath and wrapped fully around the thumb wheel.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician attempted to use a everflex entrust with a 6mm terumo as per the ifu to treat a 100mm moderately calcified lesion in the mid superficial femoral artery (sfa).The vessel was pre-dilated.No abnormalities were reported in relation to the patients anatomy.No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray.It was reported there was deployment issues.The guidewires were stuck in the stent deployment portion.The stent elongated when the wire and system was removed.The lock pin was removed prior to deployment.No resistance was encountered when advancing the device nor was excessive force used.The procedure was completed by leaving the elongated stent in the sfa.No patient harm was reported.

• 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: 7781893
• Report Number: 2183870-2018-00414
• Device Sequence Number: 1392158
• Product Code: NIP
• UDI-Device Identifier: 00821684051634
• UDI-Public: 00821684051634
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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: 10/03/2020
• Device Catalogue Number: EVD35-06-150-150
• Device Lot Number: A533934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR