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 Code	Embolism/Embolus (4438)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) trial.It was reported that an embolism occurred during the treatment of the target lesion.The subject underwent treatment with ranger drug coated balloons and eluvia drug eluting stent on (b)(6) 2021 as a part of the (b)(6) trial.The target lesion was located in the entire length of right superficial femoral artery.The lesion had a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 300 mm.The lesion was 100% stenosed and classified as tasc ii d lesion.Prior to target lesion treatment, laser atherectomy was performed with a turbo-elite catheter.Pre-dilation was performed with a 4.0 mm x 220 mm sterling percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was performed by dilatation with a 5.0 mm x 200 mm and a 6.0 mm x 200 mm ranger drug coated balloons.This was followed by a placement of 7.0 mm x 40 mm eluvia drug eluting stent.During the procedure, an embolism was noted in the target lesion.In response to the embolism, mechanical thrombectomy was performed and the complication was resolved.Post dilatation was performed with 6 mm x 40 mm mustang pta balloon and 5.0 mm x 220 mm sterling pta balloon.The final residual stenosis was noted to be 10% and thrombus was noted in the treated vessel at the end of the procedure.On (b)(6) 2021 the subject was discharged from the hospital on clopidogrel and other antiplatelet medication.There were no patient complications reported.
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).B5: describe event or problem updated to reflect there was no thrombus noted at the end of the procedure.
Event or Problem Description
Elegance clinical trial: it was reported that an embolism occurred during the treatment of the target lesion.The subject underwent treatment with ranger drug coated balloons and eluvia drug eluting stent on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was located in the entire length of right superficial femoral artery.The lesion had a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 300 mm.The lesion was 100% stenosed and classified as tasc ii d lesion.Prior to target lesion treatment, laser atherectomy was performed with a turbo-elite catheter.Pre-dilation was performed with a 4.0 mm x 220 mm sterling percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was performed by dilatation with a 5.0 mm x 200 mm and a 6.0 mm x 200 mm ranger drug coated balloons.This was followed by a placement of 7.0 mm x 40 mm eluvia drug eluting stent.During the procedure, an embolism was noted in the target lesion.In response to the embolism, mechanical thrombectomy was performed and the complication was resolved.Post dilatation was performed with 6 mm x 40 mm mustang pta balloon and 5.0 mm x 220 mm sterling pta balloon.The final residual stenosis was noted to be 10% and no thrombus was noted in the treated vessel at the end of the procedure.On (b)(6) 2021 the subject was discharged from the hospital on clopidogrel and other antiplatelet medication.There were no patient complications reported.

• 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: 12900413
• Report Number: 2134265-2021-14553
• Device Sequence Number: 4981912
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: 08714729876694
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 03/20/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027192825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Patient Race: White