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

Model Number	H74939294601010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	10/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier- (b)(6).A2: patient age at the time of enrollment- 52 years old.
Event or Problem Description
Elegance clinical study.It was reported that an occlusion of the stent occurred requiring intervention.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on 27-jun-2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right distal superficial femoral artery, right proximal popliteal artery extending up to right mid popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 440 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, atherectomy was performed using 1.5 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed using 5 mm x 200 mm non-bsc pta balloon.Treatment of target lesion was performed by dilation using study device, 5 mm x 200 mm ranger drug-coated balloon followed by placement of 6 mm x 100 mm eluvia drug eluting stent.Following post-dilation using 5 mm x 200 mm non-bsc pta balloon, the final residual stenosis was noted to be 15%.On 27-jun-2023, the subject was discharged from the hospital on dual antiplatelet therapy.On 15-oct-2023, subject was brought to the emergency department (ed) via ems with complaints of increased weakness and confusion over past few days.On the same day, ct examination performed revealed severe atherosclerotic disease with concern for bilateral femoral artery stent stenosis or occlusion.On 23-oct-2023, cta performed revealed: right leg: occlusion of sfa stents, reconstitution of popliteal artery with patchy occlusion of the distal lower extremity vessel, opacification of anterior tibial artery and peroneal artery at the level of ankle.Left leg: occluded sfa and femoral to popliteal bypass graft with reconstitution of the popliteal artery with three vessel runoffs to the level of the left ankle.Based on the findings, subject was recommended for right lower extremity angiogram and endovascular intervention.On the same day, angiogram performed revealed widely patent right cfa and profunda femoris artery, occlusion of stent extending to right mid-distal sfa, mid-distal sfa reconstitutes however, has scattered stenosis approximately 50-75 % and widely patent popliteal artery.On 03-nov-2023, 129 days post index procedure, the occlusion noted in the right sfa was treated with 4 mm standard noncompliant balloon followed placement of 5 mm x 25 mm non-bsc stent from the origin of right sfa extending to the right mid-distal sfa.Post dilation with 5 mm balloon, the final residual stenosis was noted to be less than 30%.Per edc, on 03-nov-2023, the event was resolved.Per edc, on 04-nov-2023, the subject was discharged from the hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A2: patient age at the time of enrollment- 52 years old.
Event or Problem Description
It was reported that an occlusion of the stent occurred requiring intervention.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2023 as a part of the clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right distal superficial femoral artery, right proximal popliteal artery extending up to right mid popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 440 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, atherectomy was performed using 1.5 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed using 5 mm x 200 mm non-bsc pta balloon.Treatment of target lesion was performed by dilation using study device, 5 mm x 200 mm ranger drug-coated balloon followed by placement of 6 mm x 100 mm eluvia drug eluting stent.Following post-dilation using 5 mm x 200 mm non-bsc pta balloon, the final residual stenosis was noted to be 15%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, subject was brought to the emergency department (ed) via ems with complaints of increased weakness and confusion over past few days.On the same day, ct examination performed revealed severe atherosclerotic disease with concern for bilateral femoral artery stent stenosis or occlusion.On (b)(6) 2023, cta performed revealed: right leg: occlusion of sfa stents, reconstitution of popliteal artery with patchy occlusion of the distal lower extremity vessel, opacification of anterior tibial artery and peroneal artery at the level of ankle.Left leg: occluded sfa and femoral to popliteal bypass graft with reconstitution of the popliteal artery with three vessel runoffs to the level of the left ankle.Based on the findings, subject was recommended for right lower extremity angiogram and endovascular intervention.On the same day, angiogram performed revealed widely patent right cfa and profunda femoris artery, occlusion of stent extending to right mid-distal sfa, mid-distal sfa reconstitutes however, has scattered stenosis approximately 50-75 % and widely patent popliteal artery.On (b)(6) 2023, 129 days post index procedure, the occlusion noted in the right sfa was treated with 4 mm standard noncompliant balloon followed placement of 5 mm x 25 mm non-bsc stent from the origin of right sfa extending to the right mid-distal sfa.Post dilation with 5 mm balloon, the final residual stenosis was noted to be less than 30%.Per edc, on 03-nov-2023, the event was resolved.Per edc, on (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that on (b)(6) 2023, the subject presented for protocol required 6-month visit and arterial doppler ultrasound of lower extremity revealed severely decreased perfusion of the right lower extremity (target limb).Additionally, arterial doppler ultrasound of lower extremity revealed moderately decreased perfusion of left lower extremity noted with moderately decreased digital pressures.Occlusive disease suspected to originate at the ilio-femoral artery level with subsequent femoral-popliteal level disease.On the same day, abi was noted to be 0.40 and 0.69 in right and left respectively.Furthermore, upon arrival to the emergency department on (b)(6) 2023, subject was noted to be tachycardiac and tachypneic requiring 5l of o2.Subject was also noted to be encephalopathic, dry with decreased capillary refill and a concern of sepsis.A septic work up was begun with fluids, vancomycin and zosyn.Of note, subject had small cut on the foot, which escalated to cellulitis, subject was hospitalized for several weeks in (b)(6) 2023.During the hospital stay, subject developed to mrsa bacteremia and pressure ulcer on sacrum for which wound vac was placed.On the same day, ct examination performed revealed severe atherosclerotic disease with concern for bilateral femoral artery stent stenosis or occlusion.On (b)(6) 2023, subject underwent amputation of right 5th toe due to wet gangrene.On the same day, non-invasive testing revealed abi of 0.47, toe pressure (tp) of 0 mmhg, and toe brachial index of 0.On (b)(6) 2023, blood culture was positive for mrsa and cta performed revealed: right leg: occlusion of sfa stents, reconstitution of popliteal artery with patchy occlusion of the distal lower extremity vessel, opacification of anterior tibial artery and peroneal artery at the level of ankle.Left leg: occluded sfa and femoral to popliteal bypass graft with reconstitution of the popliteal artery with three vessel runoffs to the level of the left ankle.Based on the findings, subject was recommended for right lower extremity angiogram and endovascular intervention after resolution of bacteremia.On 03-nov-2023, wifi classification assessed revealed: -wound 2: deeper wound with exposed bone, joint or tendon with gangrenous changed limited to digits.-ischemia 3: abi of <0.4, ankle systolic pressure of 50 mmhg, tp/tcpo2 <30mmhg.Foot infection 0: no symptoms or signs of infection.On the same day, angiogram performed revealed widely patent right cfa and profunda femoris artery, occlusion of stent extending to right mid-distal sfa, mid-distal sfa reconstitutes however, has scattered stenosis approximately 50-75 % and widely patent popliteal artery.
Additional Manufacturer Narrative
B5: onset date of 12-oct-2023 corrected to 02-oct-2023.A2: patient age at the time of enrollment- 52 years old.
Event or Problem Description
It was reported that an occlusion of the stent occurred requiring intervention.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2023 as a part of the clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right distal superficial femoral artery, right proximal popliteal artery extending up to right mid popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 440 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, atherectomy was performed using 1.5 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed using 5 mm x 200 mm non-bsc pta balloon.Treatment of target lesion was performed by dilation using study device, 5 mm x 200 mm ranger drug-coated balloon followed by placement of 6 mm x 100 mm eluvia drug eluting stent.Following post-dilation using 5 mm x 200 mm non-bsc pta balloon, the final residual stenosis was noted to be 15%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, subject was brought to the emergency department (ed) via ems with complaints of increased weakness and confusion over past few days.On the same day, ct examination performed revealed severe atherosclerotic disease with concern for bilateral femoral artery stent stenosis or occlusion.On (b)(6) 2023, cta performed revealed: right leg: occlusion of sfa stents, reconstitution of popliteal artery with patchy occlusion of the distal lower extremity vessel, opacification of anterior tibial artery and peroneal artery at the level of ankle.Left leg: occluded sfa and femoral to popliteal bypass graft with reconstitution of the popliteal artery with three vessel runoffs to the level of the left ankle.Based on the findings, subject was recommended for right lower extremity angiogram and endovascular intervention.On the same day, angiogram performed revealed widely patent right cfa and profunda femoris artery, occlusion of stent extending to right mid-distal sfa, mid-distal sfa reconstitutes however, has scattered stenosis approximately 50-75 % and widely patent popliteal artery.On (b)(6) 2023, 129 days post index procedure, the occlusion noted in the right sfa was treated with 4 mm standard noncompliant balloon followed placement of 5 mm x 25 mm non-bsc stent from the origin of right sfa extending to the right mid-distal sfa.Post dilation with 5 mm balloon, the final residual stenosis was noted to be less than 30%.Per edc, on (b)(6) 2023, the event was resolved.Per edc, on (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that on (b)(6) 2023, the subject presented for protocol required 6-month visit and arterial doppler ultrasound of lower extremity revealed severely decreased perfusion of the right lower extremity (target limb).Additionally, arterial doppler ultrasound of lower extremity revealed moderately decreased perfusion of left lower extremity noted with moderately decreased digital pressures.Occlusive disease suspected to originate at the ilio-femoral artery level with subsequent femoral-popliteal level disease.On the same day, abi was noted to be 0.40 and 0.69 in right and left respectively.Furthermore, upon arrival to the emergency department on (b)(6) 2023, subject was noted to be tachycardiac and tachypneic requiring 5l of o2.Subject was also noted to be encephalopathic, dry with decreased capillary refill and a concern of sepsis.A septic work up was begun with fluids, vancomycin and zosyn.Of note, subject had small cut on the foot, which escalated to cellulitis, subject was hospitalized for several weeks in (b)(6) 2023.During the hospital stay, subject developed to mrsa bacteremia and pressure ulcer on sacrum for which wound vac was placed.On the same day, ct examination performed revealed severe atherosclerotic disease with concern for bilateral femoral artery stent stenosis or occlusion.On (b)(6) 2023, subject underwent amputation of right 5th toe due to wet gangrene.On the same day, non-invasive testing revealed abi of 0.47, toe pressure (tp) of 0 mmhg, and toe brachial index of 0.On (b)(6) 2023, blood culture was positive for mrsa and cta performed revealed: right leg: occlusion of sfa stents, reconstitution of popliteal artery with patchy occlusion of the distal lower extremity vessel, opacification of anterior tibial artery and peroneal artery at the level of ankle.Left leg: occluded sfa and femoral to popliteal bypass graft with reconstitution of the popliteal artery with three vessel runoffs to the level of the left ankle.Based on the findings, subject was recommended for right lower extremity angiogram and endovascular intervention after resolution of bacteremia.On (b)(6) 2023, wifi classification assessed revealed: wound 2: deeper wound with exposed bone, joint or tendon with gangrenous changed limited to digits.Ischemia 3: abi of <0.4, ankle systolic pressure of 50 mmhg, tp/tcpo2 <30mmhg.Foot infection 0: no symptoms or signs of infection.On the same day, angiogram performed revealed widely patent right cfa and profunda femoris artery, occlusion of stent extending to right mid-distal sfa, mid-distal sfa reconstitutes however, has scattered stenosis approximately 50-75 % and widely patent popliteal artery.
Additional Manufacturer Narrative
A2: patient age at the time of enrollment- 52 years old.
Event or Problem Description
It was reported that an occlusion of the stent occurred requiring intervention.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2023 as a part of the a clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right distal superficial femoral artery, right proximal popliteal artery extending up to right mid popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 440 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, atherectomy was performed using 1.5 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed using 5 mm x 200 mm non-bsc pta balloon.Treatment of target lesion was performed by dilation using study device, 5 mm x 200 mm ranger drug-coated balloon followed by placement of 6 mm x 100 mm eluvia drug eluting stent.Following post-dilation using 5 mm x 200 mm non-bsc pta balloon, the final residual stenosis was noted to be 15%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, subject was brought to the emergency department (ed) via ems with complaints of increased weakness and confusion over past few days.On the same day, ct examination performed revealed severe atherosclerotic disease with concern for bilateral femoral artery stent stenosis or occlusion.On (b)(6) 2023, cta performed revealed: right leg: occlusion of sfa stents, reconstitution of popliteal artery with patchy occlusion of the distal lower extremity vessel, opacification of anterior tibial artery and peroneal artery at the level of ankle.Left leg: occluded sfa and femoral to popliteal bypass graft with reconstitution of the popliteal artery with three vessel runoffs to the level of the left ankle.Based on the findings, subject was recommended for right lower extremity angiogram and endovascular intervention.On the same day, angiogram performed revealed widely patent right cfa and profunda femoris artery, occlusion of stent extending to right mid-distal sfa, mid-distal sfa reconstitutes however, has scattered stenosis approximately 50-75 % and widely patent popliteal artery.On (b)(6) 2023, 129 days post index procedure, the occlusion noted in the right sfa was treated with 4 mm standard noncompliant balloon followed placement of 5 mm x 25 mm non-bsc stent from the origin of right sfa extending to the right mid-distal sfa.Post dilation with 5 mm balloon, the final residual stenosis was noted to be less than 30%.Per edc, on (b)(6) 2023, the event was resolved.Per edc, on (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that on (b)(6) 2023, the subject presented for protocol required 6-month visit and arterial doppler ultrasound of lower extremity revealed severely decreased perfusion of the right lower extremity (target limb).Additionally, arterial doppler ultrasound of lower extremity revealed moderately decreased perfusion of left lower extremity noted with moderately decreased digital pressures.Occlusive disease suspected to originate at the ilio-femoral artery level with subsequent femoral-popliteal level disease.On the same day, abi was noted to be 0.40 and 0.69 in right and left respectively.Furthermore, upon arrival to the emergency department on (b)(6) 2023, subject was noted to be tachycardiac and tachypneic requiring 5l of o2.Subject was also noted to be encephalopathic, dry with decreased capillary refill and a concern of sepsis.A septic work up was begun with fluids, vancomycin and zosyn.Of note, subject had small cut on the foot, which escalated to cellulitis, subject was hospitalized for several weeks in (b)(6) 2023.During the hospital stay, subject developed to mrsa bacteremia and pressure ulcer on sacrum for which wound vac was placed.On the same day, ct examination performed revealed severe atherosclerotic disease with concern for bilateral femoral artery stent stenosis or occlusion.On (b)(6) 2023, subject underwent amputation of right 5th toe due to wet gangrene.On the same day, non-invasive testing revealed abi of 0.47, toe pressure (tp) of 0 mmhg, and toe brachial index of 0.On (b)(6) 2023, blood culture was positive for mrsa and cta performed revealed: right leg: occlusion of sfa stents, reconstitution of popliteal artery with patchy occlusion of the distal lower extremity vessel, opacification of anterior tibial artery and peroneal artery at the level of ankle.Left leg: occluded sfa and femoral to popliteal bypass graft with reconstitution of the popliteal artery with three vessel runoffs to the level of the left ankle.Based on the findings, subject was recommended for right lower extremity angiogram and endovascular intervention after resolution of bacteremia.On (b)(6) 2023, wifi classification assessed revealed: wound 2: deeper wound with exposed bone, joint or tendon with gangrenous changed limited to digits.Ischemia 3: abi of <0.4, ankle systolic pressure of 50 mmhg, tp/tcpo2 <30mmhg.Foot infection 0: no symptoms or signs of infection.On the same day, angiogram performed revealed widely patent right cfa and profunda femoris artery, occlusion of stent extending to right mid-distal sfa, mid-distal sfa reconstitutes however, has scattered stenosis approximately 50-75 % and widely patent popliteal artery.It was further reported that baseline core-lab angiography findings for the target lesion dated (b)(6) 2023 revealed absence of aneurysm in right proximal superficial femoral artery, right mid superficial femoral artery, right distal superficial femoral artery, right proximal popliteal artery and mid popliteal artery.Post drug coated balloon, study device analysis revealed grade 0 thrombus, absence of aneurysm or perforation, timi flow of grade 0 and in segment post stenosis of 58% with dissection of grade b.Post drug eluting stent, study device analysis revealed grade 0 thrombus, absence of aneurysm or perforation, timi flow of grade 3 with dissection of grade b.

• Brand Name: ELUVIA?
• 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: 18243170
• Report Number: 2124215-2023-66854
• Device Sequence Number: 6644313
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: (01)08714729876601(17)240818(10)30161349
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 12/03/2025

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: 08/18/2024
• Device Model Number: H74939294601010
• Device Catalogue Number: H74939294601010
• Device Lot Number: 0030161349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/21/2025; 04/23/2025; 11/12/2025
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 04/22/2025; 05/20/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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: Male
• Patient Ethnicity: Hispanic
• Patient Race: White