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

Model Number 24653

Device Problems Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the stent partially deployed.The target lesion was located in the superficial femoral artery (sfa) origin.A 6x40x130 eluvia self expanding stent was selected for an endoscopic third ventriculostomy (evt) procedure.An amplatz 35 guidewire was attempted to advance to the lesion area in the sfa by brachial approach.The eluvia delivery system encountered resistance when advancing.It was noted that the eluvia expanded approximately one third around the external iliac artery (eia) and deployment continued at the eia.There were no patient complications reported.

Event Description

It was reported that the stent prematurely deployed.The target lesion was located in the superficial femoral artery (sfa) origin.A 6x40x130 eluvia self expanding stent was selected for an endoscopic third ventriculostomy (evt) procedure.An amplatz 35 guidewire was attempted to advance to the lesion area in the sfa by brachial approach.The eluvia delivery system encountered resistance when advancing.It was noted that the eluvia expanded approximately one third around the external iliac artery (eia) and deployment continued at the eia.There were no patient complications reported.It was corrected to "it was reported that the stent prematurely deployed" from "it was reported that the stent partially deployed.".

Manufacturer Narrative

(b)(6).Event sentence "it was reported that the stent partially deployed" was corrected to "it was reported that the stent prematurely deployed".

• 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: 9488438
• MDR Text Key: 173334640
• Report Number: 2134265-2019-15899
• Device Sequence Number: 1
• Product Code: NIU
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023568730
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1