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

Model Number	EVD35-07-060-150
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/07/2016
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 used the everflex entrust to treat the superficial femoral artery as per ifu.The physician advanced the everflex entrust through a previously deployed stent to reach the lesion - the stent was deployed without issue.It was reported the physician encountered difficulty removing the everflex delivery system following stent deployment.This resulted in the catheter snapping into two pieces.The catheter did not interact with the previously deployed stent and was removed from the patient on the wire.The pieces of broken catheter were removed from the patient's leg.No injury to the patient reported.
Additional Manufacturer Narrative
Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.The entrust sds was received in two pieces: a section that included the handle, strain relief, isolation sheath, and outer sheath; the second section was inner push rod/guidewire lumen.No ancillary devices or cine images from the procedure were received.The inner push rod/guidewire lumen section was examined: all components were accounted for.The handle, strain relief, isolation sheath, and outer sheath section was examined: all components were accounted for.A sharp kink was noted in the gold coloured isolation sheath just distal of the blue strain relief.A second kink was noted in the isolation sheath approximately 40.1cm distal of the proximal hub luer lock.The end of the isolation sheath was approximately 128.4cm distal of the proximal hub luer lock.The overall length of the sds was approximately 168.5cm.The safety locking tab cavity was examined: the guidewire lumen was not present.The printed strain relief was removed; the adhesive bond between the blue strain relief and the handle were separated.The handle was split open: the pull cable was still connected to the thumbwheel and outer sheath.The proximal hub luer lock was examined.Sanguine residue was noted in and on the hub.A thin film of adhesive and gold coloured residue was noted in the interior of the hub.The gold coloured residue was the same colour as the inner guidewire lumen.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6144418
• Report Number: 2183870-2016-00696
• Device Sequence Number: 13616028
• Product Code: NIP
• UDI-Device Identifier: 00821684051672
• UDI-Public: 00821684051672
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2017

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 Expiration Date: 04/27/2018
• Device Model Number: EVD35-07-060-150
• Device Lot Number: A096982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: Not provided; 01/23/2017
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 02/21/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1