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

Model Number 24657

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Elegance study: it was reported that an occlusion occurred, requiring hospitalization and bypass surgery.The subject underwent treatment with the eluvia drug-eluting stent and ranger drug coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the left mid superficial femoral artery with proximal reference vessel diameter 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 380 mm and 100% stenosis.Prior to target lesion treatment with study device, pre-dilatation was performed using 5 mm x 300 mm non-boston scientific scoring balloon and 3 mm x 200 mm non-boston scientific pta balloon.Treatment of target lesion was performed with two study devices, 6 mm x 200 mm and 5 mm x 200 mm ranger drug coated balloons and 7 mm x 120 mm, eluvia drug eluting stent.Following post dilatation was performed with 6 mm x 80 mm non-boston scientific pta balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2021, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2022, the subject was noted with the symptoms related to occluded sfa.On (b)(6)2022, the subject was hospitalized for further evaluation and treatment.On (b)(6) 2022, the subject visited the hospital with the symptoms related to peripheral artery disease.On the same date, the subject was hospitalized for further medical evaluation.In response to the event, peripheral arterial bypass was performed.

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age at time of enrollment- 63 years.

Event Description

Elegance study.It was reported that an occlusion occurred, requiring hospitalization and bypass surgery.The subject underwent treatment with the eluvia drug-eluting stent and ranger drug coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the left mid superficial femoral artery with proximal reference vessel diameter 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 380 mm and 100% stenosis.Prior to target lesion treatment with study device, pre-dilatation was performed using 5 mm x 300 mm non-boston scientific scoring balloon and 3 mm x 200 mm non-boston scientific pta balloon.Treatment of target lesion was performed with two study devices, 6 mm x 200 mm and 5 mm x 200 mm ranger drug coated balloons and 7 mm x 120 mm, eluvia drug eluting stent.Following post dilatation was performed with 6 mm x 80 mm non-boston scientific pta balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2021, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2022, the subject was noted with the symptoms related to occluded sfa.On (b)(6) 2022, the subject was hospitalized for further evaluation and treatment.On (b)(6) 2022, the subject visited the hospital with the symptoms related to peripheral artery disease.On the same date, the subject was hospitalized for further medical evaluation.In response to the event, peripheral arterial bypass was performed.It was further reported that on (b)(6) 2022, the subject presented to the hospital with the complaints of severe left lower extremity pain consistent with critical limb ischemia and subsequently peripheral angiography was performed, which revealed: -left leg: sub totally occluded common femoral artery extending into the bifurcation, 99% stenosis in profunda femoral artery, complete occlusion of superficial femoral artery, moderate distal and proximal popliteal artery disease but mid and distal popliteal artery were patent.-right leg: mild plaguing of common femoral artery, patent profundus femoral artery, mild plaguing of proximal sfa, 60-70% stenosis distal to the stented segment of distal sfa and patent popliteal artery.Based on the findings, no action was taken at this point of time.On (b)(6) 2022, subject revisited the emergency department with critical limb ischemia in the form of ischemic pain and was hospitalized on the same day for further medical treatment.On (b)(6) 2022, 306 days post index procedure, occlusion noted in the left sfa stent and femoral bifurcation was treated with endarterectomy to remove the diseased and resected left sfa stent followed by common femoral to below the knee popliteal artery bypass surgery using ipsilateral reverse greater saphenous vein.On (b)(6) 2022, foley catheter was removed and subject was started on dual antiplatelet therapy.On (b)(6) 2022, hemoglobin was dropped to 7.6 likely due to groin hematoma hence was transfused with 1 unit and hemoglobin was stabilized above 8.On (b)(6) 2022, subject discharged from the hospital and event is considered to be ongoing.

Event Description

Elegance study.It was reported that an occlusion occurred, requiring hospitalization and bypass surgery.The subject underwent treatment with the eluvia drug-eluting stent and ranger drug coated balloon on 22-dec-2021 as a part of the elegance clinical trial.The target lesion was in the left mid superficial femoral artery with proximal reference vessel diameter 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 380 mm and 100% stenosis.Prior to target lesion treatment with study device, pre-dilatation was performed using 5 mm x 300 mm non-boston scientific scoring balloon and 3 mm x 200 mm non-boston scientific pta balloon.Treatment of target lesion was performed with two study devices, 6 mm x 200 mm and 5 mm x 200 mm ranger drug coated balloons and 7 mm x 120 mm, eluvia drug eluting stent.Following post dilatation was performed with 6 mm x 80 mm non-boston scientific pta balloon, and the final residual stenosis was noted to be 10%.On (b)(6)2021, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6)2022, the subject was noted with the symptoms related to occluded sfa.On (b)(6)2022, the subject was hospitalized for further evaluation and treatment.On (b)(6)2022, the subject visited the hospital with the symptoms related to peripheral artery disease.On the same date, the subject was hospitalized for further medical evaluation.In response to the event, peripheral arterial bypass was performed.It was further reported that on (b)(6)2022, the subject presented to the hospital with the complaints of severe left lower extremity pain consistent with critical limb ischemia and subsequently peripheral angiography was performed, which revealed: -left leg: sub totally occluded common femoral artery extending into the bifurcation, 99% stenosis in profunda femoral artery, complete occlusion of superficial femoral artery, moderate distal and proximal popliteal artery disease but mid and distal popliteal artery were patent.-right leg: mild plaguing of common femoral artery, patent profundus femoral artery, mild plaguing of proximal sfa, 60-7-% stenosis distal to the stented segment of distal sfa and patent popliteal artery.Based on the findings, no action was taken at this point of time.On (b)(6)2022, subject revisited the emergency department with critical limb ischemia in the form of ischemic pain and was hospitalized on the same day for further medical treatment.On (b)(6)2022, 306 days post index procedure, occlusion noted in the left sfa stent and femoral bifurcation was treated with endarterectomy to remove the diseased and resected left sfa stent followed by common femoral to below the knee popliteal artery bypass surgery using ipsilateral reverse greater saphenous vein.On (b)(6)2022, foley catheter was removed and subject was started on dual antiplatelet therapy.On (b)(6)2022, subjects hemoglobin was dropped to 7.6 likely due to groin hematoma hence was transfused with 1 unit and hemoglobin was stabilized above 8.On (b)(6)2022, subject discharged from the hospital and event is considered to ongoing.It was again further reported that the location of intervention was in the left proximal superficial femoral artery and distal superficial femoral artery.In addition, on (b)(6)2022, subject presented to er with complaints of left leg pain and change in temperature for the last week and difficulty in walking.Subject was also endorsed that his legs had been waxing and weaning with degree of coldness and discoloration.On the same day, arterial us demonstrated diffuse low velocities throughout the left lower extremity with monophasic waveforms suggesting severe inflow stenosis.It was further reported that on (b)(6)2022, the event was considered resolved.

Manufacturer Narrative

(b)(6).

Event Description

Elegance study.It was reported that an occlusion occurred, requiring hospitalization and bypass surgery.The subject underwent treatment with the eluvia drug-eluting stent and ranger drug coated balloon on 22-dec-2021 as a part of the elegance clinical trial.The target lesion was in the left mid superficial femoral artery with proximal reference vessel diameter 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 380 mm and 100% stenosis.Prior to target lesion treatment with study device, pre-dilatation was performed using 5 mm x 300 mm non-boston scientific scoring balloon and 3 mm x 200 mm non-boston scientific pta balloon.Treatment of target lesion was performed with two study devices, 6 mm x 200 mm and 5 mm x 200 mm ranger drug coated balloons and 7 mm x 120 mm, eluvia drug eluting stent.Following post dilatation was performed with 6 mm x 80 mm non-boston scientific pta balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2021 the subject was discharged from the hospital on dual antiplatelet therapy.On 24-oct-2022, the subject was noted with the symptoms related to occluded sfa.On 24-oct-2022, the subject was hospitalized for further evaluation and treatment.On 02-nov-2022, the subject visited the hospital with the symptoms related to peripheral artery disease.On the same date, the subject was hospitalized for further medical evaluation.In response to the event, peripheral arterial bypass was performed.It was further reported that on 25-oct-2022, the subject presented to the hospital with the complaints of severe left lower extremity pain consistent with critical limb ischemia and subsequently peripheral angiography was performed, which revealed: -left leg: sub totally occluded common femoral artery extending into the bifurcation, 99% stenosis in profunda femoral artery, complete occlusion of superficial femoral artery, moderate distal and proximal popliteal artery disease but mid and distal popliteal artery were patent.-right leg: mild plaguing of common femoral artery, patent profundus femoral artery, mild plaguing of proximal sfa, 60-7-% stenosis distal to the stented segment of distal sfa and patent popliteal artery.Based on the findings, no action was taken at this point of time.On 02-nov-2022, subject revisited the emergency department with critical limb ischemia in the form of ischemic pain and was hospitalized on the same day for further medical treatment.On 02-nov-2022, 306 days post index procedure, occlusion noted in the left sfa stent and femoral bifurcation was treated with endarterectomy to remove the diseased and resected left sfa stent followed by common femoral to below the knee popliteal artery bypass surgery using ipsilateral reverse greater saphenous vein.On 03-nov-2022, foley catheter was removed and subject was started on dual antiplatelet therapy.On 04-nov-2022, subject hemoglobin was dropped to 7.6 likely due to groin hematoma hence was transfused with 1 unit and hemoglobin was stabilized above 8.On 05-nov-2022, subject discharged from the hospital and event is considered to ongoing.It was again further reported that the location of intervention was in the left proximal superficial femoral artery and distal superficial femoral artery.In addition, on 24-oct-2022, subject presented to er with complaints of left leg pain and change in temperature for the last week and difficulty in walking.Subject was also endorsed that his legs had been waxing and weaning with degree of coldness and discoloration.On the same day, arterial us demonstrated diffuse low velocities throughout the left lower extremity with monophasic waveforms suggesting severe inflow stenosis.

Manufacturer Narrative

(b)(6).

• Brand Name: ELUVIA 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15811365
• MDR Text Key: 303796536
• Report Number: 2124215-2022-46282
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027844753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White