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 Occlusion (1984)

Event Date 09/09/2020

Event Type  Injury  

Event Description

It was reported that in-stent re-occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) involving proximal popliteal artery (ppa) with 100% stenosis and was 64 mm long with a proximal reference vessel diameter of 4.79 mm and distal reference vessel diameter of 4.49 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation followed by placement of a 6 mm x 100 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged on antiplatelet therapy.On (b)(6) 2020, the subject visited the site for protocol scheduled 24-month follow-up visit.Rutherford classification was 2 (moderate claudication) and ankle brachial index (abi) ratio was 0.58.No action was taken at the time of diagnosis, intervention was planned on a later date.On (b)(6) 2020, the subject was hospitalized for planned intervention.Percutaneous transluminal angioplasty (pta) was performed to treat the event.On (b)(6) 2020, the subject underwent intervention which included recanalization with non-boston scientific catheters, atherectomy, and ballooning.Additionally, the lesion was treated with a 6 x 150mm drug-coated balloon.On (b)(6) 2020, the stent occlusion in the right sfa was considered to be resolved/recovered.On (b)(6) 2020, the subject was discharged on dual antiplatelet therapy.

• 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: 10836059
• MDR Text Key: 216119647
• Report Number: 2134265-2020-15802
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021543230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR