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

Catalog Number	EVD35-08-040-150
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use an everflex entrust device to treat stenosis in the right common iliac artery.The physician reported that when she was ready to deploy the stent it jumped off resulting in poor placement approximately 2cm proximal to the intended site.The stent remains in the patient and another stent was implanted in the left common iliac artery.
Additional Manufacturer Narrative
Additional information received (b)(6) 2018: patient age, weight & gender.Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.No ancillary devices from the procedure were received for evaluation.The everflex entrust sds was received with a kink in the catheter just distal of the blue strain relief/isolation sheath.The entrust stent delivery system was received with the red safety tab and tube removed.With the aid of magnification, it was noted that the pull cable was under tension within the handle and no kinking of the inner guidewire lumen was visible within the handle¿s safety tab cavity.Backlighting of the distal end of the sds catheter outer sheath revealed that the distal end of the inner guidewire lumen/pusher was approximately 1cm proximal of the distal end of the catheter¿s outer sheath.An examination of the sds catheter revealed a set of kinks in the silver colored sds outer sheath approximately 21.1cm and 21.7cm proximal from the distal end of the outer sheath; the gold colored isolation sheath was approximately 47.8cm proximal of the distal end of the catheter¿s outer sheath; a kink in the gold colored isolation sheath approximately 143.3cm proximal of the distal end of the catheter¿s outer sheath.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: 7517626
• Report Number: 2183870-2018-00273
• Device Sequence Number: 13809365
• Product Code: NIP
• UDI-Device Identifier: 00821684051740
• UDI-Public: 00821684051740
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2019
• Device Catalogue Number: EVD35-08-040-150
• Device Lot Number: A377742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 79