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

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

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 02/02/2021

Event Type  Injury  

Event Description

(b)(6) study.It was reported that an exacerbation of peripheral arterial disease and an occlusion of eluvia stents occurred.The subject was enrolled into the (b)(6) study on (b)(6) 2020 and the index procedure was performed on the same day.The target lesion was located in the left peroneal artery and was 90% stenosed.The lesion had a proximal reference vessel diameter of 3.25mm and distal reference vessel diameter of 3.0mm, with a lesion length of 140mm.Treatment of the target lesion was performed by placement of 3.0 mm x 120 mm standard percutaneous transluminal angioplasty balloon.Post treatment, the residual stenosis was noted to be 25%.On (b)(6) 2020, the subject was discharged on antiplatelet therapy.On (b)(6) 2021, 299 days post index procedure, the subject presented with unknown symptoms and was diagnosed to have exacerbation of peripheral arterial disease.On (b)(6) 2021, the subject was followed-up as an outpatient due to leg pain.Lower extremity arterial echo revealed blood flow from the proximal superficial femoral artery to the distal popliteal artery was not visualized.On (b)(6) 2021, prior to enrollment in the study, the subject was implanted with three eluvia stents; 7.0 mm x 120 mm, 7.0 mm x 120 mm and 7.0 mm x 80 mm in left sfa.12 months after placement of the three eluvia stents in the left sfa, an occlusion was suspected.On (b)(6) 2021, the subject was hospitalized for further evaluation and treatment.Angiography and endovascular therapy was performed on the same day to treat the event.On the same day, 100% stenosis was noted in the left peroneal artery with reference vessel diameter of 3.25mm and a lesion length of 140mm.The stenosis was treated via plain old balloon angioplasty (poba) and thrombolysis.The 100% occluded eluvia stents were treated with poba.Post procedure, the residual stenosis was noted to be 75%.Final angiography revealed no complications.Urokinase was administered intra arterially.The event was considered to be recovered/resolved.There were no patient complications reported.

• Brand Name: ELUVIATM 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 SCIMED, INC
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12913862
• MDR Text Key: 281579813
• Report Number: 2134265-2021-15160
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: Asian