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	Vascular Dissection (3160); Restenosis (4576)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier- (b)(6).Age at time of enrollment- 70 years.
Event or Problem Description
It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the proximal superficial femoral artery, mid superficial femoral artery, distal superficial femoral artery, proximal popliteal artery and mid popliteal artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 5.5 mm with lesion length of 410 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed followed by pre dilation with 4 mm x 220 mm coyote and 6 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by dilation with 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloon and implanting two eluvia drug eluting stent of 6 mm x 80 mm.Following post dilatation with 7 mm x 150 mm non-boston scientific pta balloon, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, subject visited the hospital with complaints of limited activities by previously known non healing wound on the 5th toe and hence, was referred for peripheral angiogram with possible intervention.Of note, on (b)(6) 2022, subject had visited the hospital with the complaints of critical limb ischemia with non-healing wound on left 5th toe which was treated with surgical procedure of debridement, graft and wound vac.Physical examination performed revealed 2+ bilateral radial pulses, 2+ bilateral femoral pulses.Angiogram performed on the same day revealed left mid common femoral artery: 70% stenosis with lesion length of 30 mm, left mid superficial femoral artery: 70% stenosis with lesion length of 30 mm, left anterior tibial artery: 90% stenosis, and left posterior tibial artery: 100% stenosed form ostial to distal posterior tibial artery.On (b)(6) 2022, 161 days post index procedure, 70% stenosis noted in the left mid sfa was treated with balloon angioplasty using 6 mm x 150 mm ranger drug coated balloon.In addition, 70% stenosis noted in the left mid common femoral artery was treated with 7 mm x 40 mm ranger drug coated balloon.90% stenosis noted in the left distal anterior tibial artery was treated with balloon angioplasty using 2.5 mm x 20 mm non-boston scientific hydrophilic coating balloon followed by occlusion noted in the ostial to distal posterior tibial artery was treated with non-boston scientific 2mm x 200 mm balloon.Post procedure, the final residual stenosis noted to be 10%.On (b)(6) 2022 the event was considered resolved.
Additional Manufacturer Narrative
A1: patient identifier- (b)(6).A2: age at time of enrollment- 70 years.
Event or Problem Description
It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on 22-feb-2022 as a part of the elegance clinical trial.The first target lesion was in the proximal superficial femoral artery, mid superficial femoral artery, distal superficial femoral artery, proximal popliteal artery and mid popliteal artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 5.5 mm with lesion length of 410 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed followed by pre dilation with 4 mm x 220 mm coyote and 6 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by dilation with 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloon and implanting two eluvia drug eluting stent of 6 mm x 80 mm.Following post dilatation with 7 mm x 150 mm non-boston scientific pta balloon, the final residual stenosis was noted to be 20%.On 24-feb-2022, the subject was discharged on aspirin and clopidogrel.On 02-aug-2022, subject visited the hospital with complaints of limited activities by previously known non healing wound on the 5th toe and hence, was referred for peripheral angiogram with possible intervention.Of note, on 08-jun-2022, subject had visited the hospital with the complaints of critical limb ischemia with non-healing wound on left 5th toe which was treated with surgical procedure of debridement, graft and wound vac.Physical examination performed revealed 2+ bilateral radial pulses, 2+ bilateral femoral pulses.Angiogram performed on the same day revealed left mid common femoral artery: 70% stenosis with lesion length of 30 mm, left mid superficial femoral artery: 70% stenosis with lesion length of 30 mm, left anterior tibial artery: 90% stenosis, and left posterior tibial artery: 100% stenosed form ostial to distal posterior tibial artery.On 02-aug-2022, 161 days post index procedure, 70% stenosis noted in the left mid sfa was treated with balloon angioplasty using 6 mm x 150 mm ranger drug coated balloon.In addition, 70% stenosis noted in the left mid common femoral artery was treated with 7 mm x 40 mm ranger drug coated balloon.90% stenosis noted in the left distal anterior tibial artery was treated with balloon angioplasty using 2.5 mm x 20 mm non-boston scientific hydrophilic coating balloon followed by occlusion noted in the ostial to distal posterior tibial artery was treated with non-boston scientific 2mm x 200 mm balloon.Post procedure, the final residual stenosis noted to be 10%.On 03-aug-2022 the event was considered resolved.It was further reported that the in-stent restenosis was not caused by either of the ranger drug coated balloons.Causality of the eluvia drug eluting stents is possible.
Additional Manufacturer Narrative
(b(6).
Event or Problem Description
It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the proximal superficial femoral artery, mid superficial femoral artery, distal superficial femoral artery, proximal popliteal artery and mid popliteal artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 5.5 mm with lesion length of 410 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed followed by pre dilation with 4 mm x 220 mm coyote and 6 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by dilation with 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloon and implanting two eluvia drug eluting stent of 6 mm x 80 mm.Following post dilatation with 7 mm x 150 mm non-boston scientific pta balloon, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, subject visited the hospital with complaints of limited activities by previously known non healing wound on the 5th toe and hence, was referred for peripheral angiogram with possible intervention.Of note, on (b)(6) 2022, subject had visited the hospital with the complaints of critical limb ischemia with non-healing wound on left 5th toe which was treated with surgical procedure of debridement, graft and wound vac.Physical examination performed revealed 2+ bilateral radial pulses, 2+ bilateral femoral pulses.Angiogram performed on the same day revealed left mid common femoral artery: 70% stenosis with lesion length of 30 mm, left mid superficial femoral artery: 70% stenosis with lesion length of 30 mm, left anterior tibial artery: 90% stenosis, and left posterior tibial artery: 100% stenosed form ostial to distal posterior tibial artery.On (b)(6) 2022, 161 days post index procedure, 70% stenosis noted in the left mid sfa was treated with balloon angioplasty using 6 mm x 150 mm ranger drug coated balloon.In addition, 70% stenosis noted in the left mid common femoral artery was treated with 7 mm x 40 mm ranger drug coated balloon.90% stenosis noted in the left distal anterior tibial artery was treated with balloon angioplasty using 2.5 mm x 20 mm non-boston scientific hydrophilic coating balloon followed by occlusion noted in the ostial to distal posterior tibial artery was treated with non-boston scientific 2mm x 200 mm balloon.Post procedure, the final residual stenosis noted to be 10%.On (b)(6) 2022 the event was considered resolved.It was further reported that the in-stent restenosis was not caused by either of the ranger drug coated balloons.Causality of the eluvia drug eluting stents is possible.It was again further reported that causality of the ranger drug coated balloons is possible.
Additional Manufacturer Narrative
A1: patient identifier- (b)(6).A2: age at time of enrollment- 70 years.
Event or Problem Description
It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on 22-feb-2022 as a part of the elegance clinical trial.The first target lesion was in the proximal superficial femoral artery, mid superficial femoral artery, distal superficial femoral artery, proximal popliteal artery and mid popliteal artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 5.5 mm with lesion length of 410 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed followed by pre dilation with 4 mm x 220 mm coyote and 6 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by dilation with 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloon and implanting two eluvia drug eluting stent of 6 mm x 80 mm.Following post dilatation with 7 mm x 150 mm non-boston scientific pta balloon, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, subject visited the hospital with complaints of limited activities by previously known non healing wound on the 5th toe and hence, was referred for peripheral angiogram with possible intervention.Of note, on (b)(6) 2022, subject had visited the hospital with the complaints of critical limb ischemia with non-healing wound on left 5th toe which was treated with surgical procedure of debridement, graft and wound vac.Physical examination performed revealed 2+ bilateral radial pulses, 2+ bilateral femoral pulses.Angiogram performed on the same day revealed left mid common femoral artery: 70% stenosis with lesion length of 30 mm, left mid superficial femoral artery: 70% stenosis with lesion length of 30 mm, left anterior tibial artery: 90% stenosis, and left posterior tibial artery: 100% stenosed form ostial to distal posterior tibial artery.On (b)(6) 2022, 161 days post index procedure, 70% stenosis noted in the left mid sfa was treated with balloon angioplasty using 6 mm x 150 mm ranger drug coated balloon.In addition, 70% stenosis noted in the left mid common femoral artery was treated with 7 mm x 40 mm ranger drug coated balloon.90% stenosis noted in the left distal anterior tibial artery was treated with balloon angioplasty using 2.5 mm x 20 mm non-boston scientific hydrophilic coating balloon followed by occlusion noted in the ostial to distal posterior tibial artery was treated with non-boston scientific 2mm x 200 mm balloon.Post procedure, the final residual stenosis noted to be 10%.On (b)(6) 2022 the event was considered resolved.It was further reported that the in-stent restenosis was not caused by either of the ranger drug coated balloons.Causality of the eluvia drug eluting stents is possible.It was again further reported that causality of the ranger drug coated balloons is possible.It was again further reported that the onset date of the event was (b)(6) 2022.It was again further reported that the final residual stenosis after the index procedure was 5%.
Additional Manufacturer Narrative
A1: patient identifier- (b)(6).A2: age at time of enrollment- 70 years.
Event or Problem Description
It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the proximal superficial femoral artery, mid superficial femoral artery, distal superficial femoral artery, proximal popliteal artery and mid popliteal artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 5.5 mm with lesion length of 410 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed followed by pre dilation with 4 mm x 220 mm coyote and 6 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by dilation with 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloon and implanting two eluvia drug eluting stent of 6 mm x 80 mm.Following post dilatation with 7 mm x 150 mm non-boston scientific pta balloon, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, subject visited the hospital with complaints of limited activities by previously known non healing wound on the 5th toe and hence, was referred for peripheral angiogram with possible intervention.Of note, on (b)(6) 2022, subject had visited the hospital with the complaints of critical limb ischemia with non-healing wound on left 5th toe which was treated with surgical procedure of debridement, graft and wound vac.Physical examination performed revealed 2+ bilateral radial pulses, 2+ bilateral femoral pulses.Angiogram performed on the same day revealed left mid common femoral artery: 70% stenosis with lesion length of 30 mm, left mid superficial femoral artery: 70% stenosis with lesion length of 30 mm, left anterior tibial artery: 90% stenosis, and left posterior tibial artery: 100% stenosed form ostial to distal posterior tibial artery.On (b)(6) 2022, 161 days post index procedure, 70% stenosis noted in the left mid sfa was treated with balloon angioplasty using 6 mm x 150 mm ranger drug coated balloon.In addition, 70% stenosis noted in the left mid common femoral artery was treated with 7 mm x 40 mm ranger drug coated balloon.90% stenosis noted in the left distal anterior tibial artery was treated with balloon angioplasty using 2.5 mm x 20 mm non-boston scientific hydrophilic coating balloon followed by occlusion noted in the ostial to distal posterior tibial artery was treated with non-boston scientific 2mm x 200 mm balloon.Post procedure, the final residual stenosis noted to be 10%.On (b)(6) 2022 the event was considered resolved.It was further reported that the in-stent restenosis was not caused by either of the ranger drug coated balloons.Causality of the eluvia drug eluting stents is possible.It was again further reported that causality of the ranger drug coated balloons is possible.It was again further reported that the onset date of the event was (b)(6) 2022.
Additional Manufacturer Narrative
A2: age at time of enrollment- 70 years old.B5: updated based on additional information.
Event or Problem Description
It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the clinical trial.The first target lesion was in the proximal superficial femoral artery, mid superficial femoral artery, distal superficial femoral artery, proximal popliteal artery and mid popliteal artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 5.5 mm with lesion length of 410 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed followed by pre dilation with 4 mm x 220 mm coyote and 6 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by dilation with 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloon and implanting two eluvia drug eluting stent of 6 mm x 80 mm.Following post dilatation with 7 mm x 150 mm non-boston scientific pta balloon, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, subject visited the hospital with complaints of limited activities by previously known non-healing wound on the 5th toe and hence, was referred for peripheral angiogram with possible intervention.Of note, on (b)(6) 2022, subject had visited the hospital with the complaints of critical limb ischemia with non-healing wound on left 5th toe which was treated with surgical procedure of debridement, graft and wound vac.Physical examination performed revealed 2+ bilateral radial pulses, 2+ bilateral femoral pulses.Angiogram performed on the same day revealed left mid common femoral artery: 70% stenosis with lesion length of 30 mm, left mid superficial femoral artery: 70% stenosis with lesion length of 30 mm, left anterior tibial artery: 90% stenosis, and left posterior tibial artery: 100% stenosed form ostial to distal posterior tibial artery.On (b)(6) 2022, 161 days post index procedure, 70% stenosis noted in the left mid sfa was treated with balloon angioplasty using 6 mm x 150 mm ranger drug coated balloon.In addition, 70% stenosis noted in the left mid common femoral artery was treated with 7 mm x 40 mm ranger drug coated balloon.90% stenosis noted in the left distal anterior tibial artery was treated with balloon angioplasty using 2.5 mm x 20 mm non-boston scientific hydrophilic coating balloon followed by occlusion noted in the ostial to distal posterior tibial artery was treated with non-boston scientific 2mm x 200 mm balloon.Post procedure, the final residual stenosis noted to be 10%.On (b)(6) 2022 the event was considered resolved.It was further reported that the in-stent restenosis was not caused by either of the ranger drug coated balloons.Causality of the eluvia drug eluting stents is possible.It was again further reported that causality of the ranger drug coated balloons is possible.It was again further reported that the onset date of the event was 08-jun-2022.It was again further reported that the final residual stenosis after the index procedure was 5%.It was further reported that on the day of intervention, the left distal popliteal artery was not treated by any of the study devices.Furthermore, during the index procedure, dissection complication of grade d was noted in target lesion due to subintimal wiring which was treated by placement of bailout stent and the complication was resolved.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15400714
• Report Number: 2124215-2022-34464
• Device Sequence Number: 5006890
• Product Code: NIU
• UDI-Device Identifier: 08714729876595
• UDI-Public: 08714729876595
• 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: 2022
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/05/2025

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: 02/04/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0026951624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 11/29/2022; 11/15/2023; 12/08/2023; 04/29/2025
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/23/2022; 12/14/2022; 11/21/2023; 12/13/2023; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White