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

Catalog Number	EVD35-07-120-120
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician had intended to use an everflex entrust 7x120x120 to treat a plaque lesion in the left proximal sfa.The lesion was moderately calcified and had a length of 100 mm.The artery was 6 mm and had 80% stenosis.No abnormalities were reported in relation to the patient's anatomy.The procedure used a 7 fr non medtronic sheath and a 0.035" guide wire.The everflex entrust device was prepped as per the ifu.The packaging of the device was fully intact.It was noticed after the stent entered the patient that the stent was the incorrect length.This was identified by measuring using fluoroscopy and the markers.The stent was removed from the body and was not deployed.The procedure was completed by pre-dilating the lesion with a size 6 pre-dilation device and using a 7x100 everflex entrust stent.No patient injury was reported.The physician had intended to use an everflex stent with entrust delivery system, 7x120x120 to treat a plaque lesion in the left proximal sfa.The lesion was moderately calcified and had a length of 100 mm.The artery was 6 mm and had 80% stenosis.No abnormalities were reported in relation to the patient's anatomy.The procedure used a 7 fr non-medtronic sheath and a 0.035" guide wire.The everflex entrust device was prepped as per the ifu.The packaging of the device was fully intact.It was reported that after the stent entered the patient¿s body, it was noticed that the stent was the incorrect length.This was identified by measuring using fluoroscopy and the markers.The stent was removed from the body and was not deployed.The procedure was completed by pre-dilating the lesion with a size 6 pre-dilation device and using a 7x100 everflex entrust stent.No patient injury was reported.
Additional Manufacturer Narrative
Additional info: device evaluation summary: the device was returned for evaluation.The printed strain relief on the returned entrust delivery system indicated that it contains a 7mm by 120mm stent, which corresponds with the returned shelf carton label.Several kinks were noted in the entrust delivery system catheter.Backlighting was used to determine if the stent was still within the entrust delivery system, the location of the proximal end of the stent, and the location of the distal end of the inner guidewire lumen/pusher.The proximal end of the stent was marked on the outer sheath with permanent marker.The length of the stent within the entrust delivery system was approximately 6cm.The distal tip was examined: no abnormality or deformity was found.Sanguine residue was noted within the lumen of the outer sheath and on the exterior of the outer sheath.A 20cc water filled syringe with manometer was attached to the proximal hub luer lock the entrust delivery system was pressurized to 20 atm before the sanguine residue within the entrust lumen began to exit the distal tip of the delivery system.A 0.035¿ guidewire was loaded through the distal tip and would only advance to kink in the catheter.The red locking pin and tube were removed from the entrust delivery system handle with ease.The thumbwheel was advanced and the stent deployed with ease.The stent was examined no abnormality or deformity was noted.The overall length of the stent was 60mm and the diameter of the stent was 7mm.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: 6960377
• Report Number: 2183870-2017-00458
• Device Sequence Number: 11086971
• Product Code: NIP
• UDI-Device Identifier: 00821684051467
• UDI-Public: 00821684051467
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2017

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 Catalogue Number: EVD35-07-120-120
• Device Lot Number: A476301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2183870-11-06-2017-001-R
• Patient Sequence Number: 1