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

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

This is a combination device.

Event Description

It was reported that stent damage occurred.A procedure in the superficial femoral artery (sfa) was performed to treat a restenosed non-bsc stent.An eluvia self expanding drug eluting stent was successfully implanted using a.014 non-bsc guidewire.A second eluvia device, 6x120x130, was selected for implant however, it was unable to cross the lesion.A coyote es 4x40x146 balloon was selected and that device also failed to cross the lesion.The guidewire was attempted to be removed but was stuck in the lesion.An attempt was made to remove the guidewire via snare which was unsuccessful and the wire was surgically removed from the patient.The stent strut of the implanted eluvia device is suspected to be lifted due to the guidewire being pushed into and possibly stuck within it.It was confirmed the edge of the stent was moved.No known patient complications have been initially reported however, the condition post procedure is being confirmed.

• Brand Name: ELUVIATM 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10221122
• MDR Text Key: 197316836
• Report Number: 2134265-2020-08728
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1