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

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  Death  

Manufacturer Narrative

A1: patient id: (b)(6).A2: patient age: 73 years old at time of enrollment.

Event Description

Elegance clinical study.It was reported that the subject passed away.On (b)(6) 2023, the subject underwent treatment with eluvia drug eluting stents as part of the elegance clinical trial.The target lesion was located in the 100% stenosed left proximal superficial femoral artery (sfa) extending up to the left mid-sfa; with a 5 mm proximal reference vessel diameter, and a 5 mm distal reference vessel diameter, with a 240 mm lesion length.The lesion was classified as transatlantic intersociety consensus (tasc) ii c lesion.Prior to the treatment of the target lesion with the study devices, pre-dilation was performed using 6 mm x 150 mm and 5 mm x 120 mm percutaneous transluminal angioplasty balloon.Treatment of the target lesion was then performed by placement of two 6 mm x 120 mm drug eluting stents, and one 6 mm x 40 mm eluvia drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2023, the subject was discharged from the hospital on dual anti-platelet therapy.On approximately (b)(6) 2023, the subject passed away.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18907512
• MDR Text Key: 337703142
• Report Number: 2124215-2024-15173
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0029684507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ELUVIA DRUG ELUTING VASCULAR STENTS
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Race: Asian