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

Model Number 24657

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976); Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 02/13/2019

Event Type  Injury  

Event 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 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8404798
• MDR Text Key: 138268928
• Report Number: 2134265-2019-02022
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7FR TERUMO DESTINATION SHEATH; 7FR TERUMO DESTINATION SHEATH; TERUMO GLIDEWIRE; TERUMO GLIDEWIRE; 7FR TERUMO DESTINATION SHEATH; TERUMO GLIDEWIRE
• Patient Outcome(s): Required Intervention