MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	24657
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Deformation (2976); Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage and migration occurred.A 6x60 eluvia was selected to treat a lesion located in the proximal superficial femoral artery (sfa).During stent deployment, the catheter sheath caught the stent and pulled the stent backwards proximally.The stent elongated as a result.The stent was deployed; however, in a more proximal location than intended.A long sheath was advanced through the eluvia stent which caused the eluvia to move slightly.A 7x80 innova was then deployed to "smooth out" the eluvia stent and connect it to a previously deployed stent in the sfa.The procedure was completed.There were no patient complications.
Event or Problem Description
It was reported that stent damage and migration occurred.A 6x60 eluvia was selected to treat a lesion located in the proximal superficial femoral artery (sfa).During stent deployment, the catheter sheath caught the stent and pulled the stent backwards proximally.The stent elongated as a result.The stent was deployed; however, in a more proximal location than intended.A long sheath was advanced through the eluvia stent which caused the eluvia to move slightly.A 7x80 innova was then deployed to "smooth out" the eluvia stent and connect it to a previously deployed stent in the sfa.The procedure was completed.There were no patient complications.Additional information reported that there were no issues with the deployment mechanism.The physician went up and over using a 7f sheath.The degree of tortuosity and calcification was minor.The lesion was 100% stenosed.Prior to the eluvia being used, athrectomy and poba were performed resulting in 50-70% residual stenosis.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8404798
• Report Number: 2134265-2019-02022
• Device Sequence Number: 13520236
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• 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): 03/25/2019

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: 02/25/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 22661050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7FR TERUMO DESTINATION SHEATH; 7FR TERUMO DESTINATION SHEATH; TERUMO GLIDEWIRE; TERUMO GLIDEWIRE; 7FR TERUMO DESTINATION SHEATH; TERUMO GLIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention