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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation along with the second device involved in this event.The entrust sds was received with approximately 3.5 rows(1.5cm of the 150mm stent) of stent cells exposed and flowered.The entrust sds was received locked up on a 0.0175¿ guidewire.The entrust sds was received with the red safety tab and tube removed from the handle.Neither the red safety tab nor the tube were returned with the sds.The handle¿s safety tab cavity was examined: the inner guidewire lumen was kinked within the handle.The distal end of the inner guidewire lumen/pusher was not in contact with the proximal end of the stent.The entire working length of the entrust sds was examined: no kinks or twists were noted in the catheter.The strain relief was removed and the handle was split opened along its seam.The inner guidewire lumen was kinked several times in the area of the safety cavity of the handle.The pull cable was received properly routed within the handle and still attached to the thumb wheel.The proximal end of the sds catheter¿s outer sheath was examined.The kinked inner guidewire lumen was straightened out to allow the blue and gold isolation sheaths to be slid proximal over the inner guidewire lumen.The pull cable remained properly bonded to the proximal end of the catheter¿s outer sheath.The returned entrust sds was locked up on the 0.018¿ compatible guidewire due to kinks within the entrust delivery handle safety tab cavity.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician attempted to use a 6 x 150 everflex entrust device to treat a moderately tortuous and calcified left distal sfa 120mm lesion exhibiting (b)(4)% stenosis.Access was through the left brachial artery.The vessel diameter was reported to be 6mm in diameter.A non-medtronic 6f sheath and a non-mdt 018 guidewire were used.Embolic protection was not used.The device was removed from its packaging and inspected with no issues noted.The ifu was followed during prep.The lesion was predilated with a 4mm device.The device passed through a previously deployed aaa endograft stent which had a pronounced angle in the aorta at the level of the renal arteries.It was reported that the device would not deploy and the device was withdrawn.The lesion area was then redilated with a 6mm balloon.The physician then opened a new 7 x 150 everlfex entrust device.The physician encountered difficulty but did succeed in deploying the second stent.No patient injury was reported.After stent deployment, the lesion was post dilated.

• 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: 7636987
• Report Number: 2183870-2018-00347
• Device Sequence Number: 2512612
• Product Code: NIP
• UDI-Device Identifier: 00821684051634
• UDI-Public: 00821684051634
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: 01/22/2021
• Device Catalogue Number: EVD35-06-150-150
• Device Lot Number: A585712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 59