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 Problems Ischemia (1942); Thrombosis (2100)

Event Date 07/18/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

(b)(6) study.It was reported that stent thrombosis and ischemia occurred.The subject underwent treatment with a study device on (b)(6) 2020 as part of the (b)(6) trial.The target lesion was located in left proximal superficial femoral artery (sfa) with 100% stenosis.The lesion was 100 mm long with a proximal reference vessel of 5 mm and a distal reference vessel diameter of 5 mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation followed by placement of four 6 mm x 120 mm stents.Following post dilation, the residual stenosis was 0%.On (b)(6) 2020, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2020, dissection flap in the target vessel.On (b)(6) 2020, the subject was hospitalized due to ischemia in left leg.Diagnosis revealed presence of thrombus in the stent.Subsequently, the subject also developed myocardial infarction for which medication was given as a treatment.No treatment was given for ischemia in target limb.On (b)(6) 2020, the subject died due to myocardial infarction unrelated to the stent.The event was considered not recovered/ not resolved.

• 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: 10718672
• MDR Text Key: 212511085
• Report Number: 2134265-2020-14557
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023737971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR