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

Model Number 24653

Device Problem Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: (b)(6) at time of enrollment.

Event Description

Eminent clinical study.It was reported that the stent failed to expand.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in left mid superficial femoral artery (sfa) with 70% stenosis and was 30 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm.It was classified as tasc ii a lesion.The target lesion was treated with direct placement of 6 mm x 40 mm study stent.Following this intervention, the stent did not open enough.Two post balloon dilations were performed to open the stent and the lesion was treated successfully with 0% residual stenosis.On (b)(6) 2019, the event was considered recovered/resolved.On (b)(6) 2019, the subject was discharged on aspirin.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10014045
• MDR Text Key: 189696036
• Report Number: 2134265-2020-05777
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023220240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention