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

Model Number 24653

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

Patient Problems Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 11/21/2022

Event Type  Injury  

Event Description

Elegance clinical trial.It was reported that in-stent occlusion occurred.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid sfa extending up to left distal sfa with 5.5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 85 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilatation was performed using 5 mm x 250 mm non-boston scientific pta balloon and 5 mm x 220 mm non-boston scientific pta balloon.Treatment of target lesion was performed by using study device of size 6 mm x 100 mm, eluvia drug eluting stent.Following post dilatation was performed with 6 mm x 100 mm mustang pta balloon and the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged form hospital on dual antiplatelet therapy.On (b)(6) 2022, subject was noted with symptoms related to atherosclerotic occlusive disease in lower extremity.Subsequently lower extremity angiography was performed which revealed femoral artery occlusion.In response to event, lower extremity arterial balloon dilatation and percutaneous femoral artery thrombectomy were performed.On (b)(6) 2022 , the event was considered resolved.

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: 56 years old at the time of study enrollment.Initial reporter facility name: (b)(6).Hospital (b)(6).University.

Event Description

Elegance clinical trial.It was reported that in-stent occlusion occurred.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid sfa extending up to left distal sfa with 5.5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 85 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilatation was performed using 5 mm x 250 mm non-boston scientific pta balloon and 5 mm x 220 mm non-boston scientific pta balloon.Treatment of target lesion was performed by using study device of size 6 mm x 100 mm, eluvia drug eluting stent.Following post dilatation was performed with 6 mm x 100 mm mustang pta balloon and the final residual stenosis was noted to be 0%.On 07-jul-2022, the subject was discharged form hospital on dual antiplatelet therapy.On (b)(6) 2022, subject was noted with symptoms related to atherosclerotic occlusive disease in lower extremity.Subsequently lower extremity angiography was performed which revealed femoral artery occlusion.In response to event, lower extremity arterial balloon dilatation and percutaneous femoral artery thrombectomy were performed.On (b)(6) 2022, the event was considered resolved.It was further reported that on (b)(6) 2022, subject visited the hospital with worsening symptoms of intermittent claudication of bilateral lower limbs for past two weeks and was hospitalized on the same day for further medical evaluation and treatment.Of note, abi examination performed at an outside hospital revealed 0.94 on the right leg and 0.59 on the left leg.Subsequently, rutherford classification assessed on the same day revealed category 1 with mild intermittent claudication at a walking distance of less than 200 mm and presence of pulse at left sfa, however, absence of pulse at left popliteal artery, left dorsalis pedis artery, and left posterior tibial artery.Additionally, ct angiography performed revealed slight hyperplasia of stent intima in left sfa with occlusion of the upper segment of the left femoral artery stent and lower segment of left femoral artery and multiple stenosis of the bilateral internal iliac artery.Based on these findings, subject was planned for lower limb angiography with pta and stent implantation.On (b)(6) 2022, left lower limb angiography was performed which revealed stent shadow seen at the initial segment of the sfa, development of the sfa and popliteal artery at the distal end of the in-stent occlusion was delayed via the collateral branches, and the three branches under the knee were developed faintly.On the same day, in response to event, occlusion noted in the distal sfa was pre-dilated with 3 mm x 150 mm non-boston scientific balloon.Angiography performed post balloon dilation revealed severe residual stenosis in the stent with large number of thrombotic lesions which was treated with non-boston scientific aspiration thrombectomy and subsequently drug coated balloon angioplasty was performed using 4 mm x 200 mm and 5 mm x 100 mm balloon to treat the residual thrombus and sclerotic plaque.Post procedural angiography revealed residual plaque at the proximal end of the stent and intima of the distal end of the sfa, however the flow rate was significantly increased.

Manufacturer Narrative

A1: patient identifier:(b)(6).A2: age at time of event: 56 years old at the time of study enrollment.E1: initial reporter facility name: (b)(6) hospital - (b)(6).

Manufacturer Narrative

A1: patient identifier: (b)(6) a2: age at time of event: 56 years old at the time of study enrollment.E1: initial reporter facility name: (b)(6) hospital.

Event Description

Elegance clinical trial it was reported that in-stent occlusion occurred.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid sfa extending up to left distal sfa with 5.5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 85 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilatation was performed using 5 mm x 250 mm non-boston scientific pta balloon and 5 mm x 220 mm non-boston scientific pta balloon.Treatment of target lesion was performed by using study device of size 6 mm x 100 mm, eluvia drug eluting stent.Following post dilatation was performed with 6 mm x 100 mm mustang pta balloon and the final residual stenosis was noted to be 0%.On 07-jul-2022, the subject was discharged form hospital on dual antiplatelet therapy.On (b)(6) 2022, subject was noted with symptoms related to atherosclerotic occlusive disease in lower extremity.Subsequently lower extremity angiography was performed which revealed femoral artery occlusion.In response to event, lower extremity arterial balloon dilatation and percutaneous femoral artery thrombectomy were performed.On (b)(6) 2022, the event was considered resolved.It was further reported that on (b)(6) 2022, subject visited the hospital with worsening symptoms of intermittent claudication of bilateral lower limbs for past two weeks and was hospitalized on the same day for further medical evaluation and treatment.Of note, abi examination performed at an outside hospital revealed 0.94 on the right leg and 0.59 on the left leg.Subsequently, rutherford classification assessed on the same day revealed category 1 with mild intermittent claudication at a walking distance of less than 200 mm and presence of pulse at left sfa, however, absence of pulse at left popliteal artery, left dorsalis pedis artery, and left posterior tibial artery.Additionally, ct angiography performed revealed slight hyperplasia of stent intima in left sfa with occlusion of the upper segment of the left femoral artery stent and lower segment of left femoral artery and multiple stenosis of the bilateral internal iliac artery.Based on these findings, subject was planned for lower limb angiography with pta and stent implantation.On (b)(6) 2022, left lower limb angiography was performed which revealed stent shadow seen at the initial segment of the sfa, development of the sfa and popliteal artery at the distal end of the in-stent occlusion was delayed via the collateral branches, and the three branches under the knee were developed faintly.On the same day, in response to event, occlusion noted in the distal sfa was pre-dilated with 3 mm x 150 mm non-boston scientific balloon.Angiography performed post balloon dilation revealed severe residual stenosis in the stent with large number of thrombotic lesions which was treated with non-boston scientific aspiration thrombectomy and subsequently drug coated balloon angioplasty was performed using 4 mm x 200 mm and 5 mm x 100 mm balloon to treat the residual thrombus and sclerotic plaque.Post procedural angiography revealed residual plaque at the proximal end of the stent and intima of the distal end of the sfa, however the flow rate was significantly increased.It was further reported that the target lesion was in the left proximal sfa only.The eluvia stent was implanted in the left proximal sfa.On (b)(6)2022, 140 days post index procedure, in-stent thrombotic occlusion was noted in the proximal sfa.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: 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: 16034216
• MDR Text Key: 305995687
• Report Number: 2124215-2022-54101
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0026100086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: Asian