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

Model Number	24657
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Obstruction/Occlusion (2422)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) clinical trial.It was reported that 13 days post-index the patient had bilateral worsening limb ischemia and stent occlusion.The subject underwent treatment with the eluvia drug eluting stents on (b)(6) 2022 as a part of the (b)(6) clinical trial.The target lesion was in left proximal superficial femoral artery (sfa), mid sfa and mid popliteal artery.The lesion had a 6.0 mm proximal reference vessel diameter and 4.0 mm distal reference vessel diameter, which a total lesion length of 420 mm and 99% stenosis and classified as tasc ii lesion.Prior to target lesion treatment, balloon dilation was performed with 4.0 x 120 mm and 5.0 x 80 mm charger pta balloons.Treatment of target lesion was performed by placement of study device, eluvia drug eluting stents of sizes 6 mm x 120 mm, 7 mm x 60 mm, 7 mm x 120 mm and 7 mm x 120 mm.Post treatment of target lesion, dilatation was performed with 4.0 mm x 60 mm, 4.0 mm x 200 mm, 5.0 mm x 60 mm, 5.0 mm x 120 mm and 6.0 mm x 150 mm charger pta balloons and the final residual stenosis was noted to be 0%.On (b)(6) 2022, subject was discharged from hospital on dual antiplatelet therapy.On (b)(6) 2022, 13 days post index procedure, subject presented to the emergency department with the complaint of bilateral lower extremity rest pain.On evaluation, the subject was noted with bilateral worsening limb ischemia.The subject reported that they had not taken any of his medications for the last couple of weeks.Upon admission, the lower extremity angiography revealed a new total occlusion of the left and right superficial femoral artery with occluded stents since the previous exam, and reconstitution at the popliteal artery level and single (left) and two-vessel (right) runoff of the level of the ankle.The subject was recommended for bilateral lower-extremity amputation, however subject refused with second opinion at another facility.The subject was started on heparin gtt, and remained hemodynamically stable, tolerating a carb-controlled diet and demonstrated baseline function.On (b)(6) 2022, subject demonstrated hemodynamic stability and deemed appropriate for discharge.On the same day, the subject was discharged from the hospital.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: 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: 14591257
• Report Number: 2134265-2022-05672
• Device Sequence Number: 19357311
• Product Code: NIU
• UDI-Device Identifier: 08714729876700
• UDI-Public: 08714729876700
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028380999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Black Or African American