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 Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/28/2019
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
Physician was attempting to implant an everflex entrust self expanding stent with a 7fr sheath to treat a severely calcified lesion in the right proximal common iliac to sfa with a chronic total occlusion (cto-100%).The vessel diameter and lesion length was 5mmand 120mm respectively.The vessel was severely tortuous.There was no damage noted to packaging.No issues noted when removing the device from the hoop/tray.Device was prepped per ifu with no issues identified.There was deployment issue, with the stent partially deployed.Resistance was encountered during delivery to lesion with force applied.The device did not pass through a previously deployed stent.There was no damage to the deployment mechanisms or device handle prior to deployment issue.The thumbscrew/lock-pin was checked for securement prior to procedure.The lesion was pre dilated using a 5.0 balloon.It was reported that stent was advanced partially through a distal sfa and popliteal lesion.Stent partially deployed approximately 20mm of the stent.The stent was dr agged through the sheath and retrieved.After stent retrieval, it was discovered that part of the stent (the part that had been deployed), had separated and was left in the contra lateral side somewhere between the skin and tissue.Patient was stable but was later transferred to the hospital due to groin bleed.Ct was done and patient groin stopped bleeding at hospital there was no other adverse event.Another stent over 035 wire was used to complete the procedure.There was no patient injury reported.
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 LONG
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9070537
• Report Number: 2183870-2019-00453
• Device Sequence Number: 14085718
• Product Code: NIP
• UDI-Device Identifier: 00821684051634
• UDI-Public: 00821684051634
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 06/24/2022
• Device Catalogue Number: EVD35-06-150-150
• Device Lot Number: A854140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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: Hospitalization