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 Thrombosis/Thrombus (4440)

Event Date 07/12/2023

Event Type  Injury  

Event Description

S2444 elegance it was reported that the subject experienced acute thrombosis of the left superficial femoral artery (sfa), including the newly placed eluvia drug-eluting stents, during the index procedure.The subject underwent treatment with the ranger drug coated balloons and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left proximal and distal sfa, with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 5 mm.The target lesion was 200 mm long and 100% stenosed and was thus classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using 4.0 mm x 220 mm sterling pta balloon.Following pre-dilation, the target lesion experienced recoiling.Treatment of target lesion was performed by placement of two 6 mm x 120 mm eluvia drug eluting stents.Post target lesion treatment, 6 mm x 250 mm and 6 mm x 100 mm non-bsc stent graft stents was placed.Following post-dilation ranger drug coated balloons of sizes 5 mm x 200 mm and 6 mm x 200 mm, the final residual stenosis was noted to be 30%.On (b)(6) 2023, during the index procedure, intra-op angiography performed revealed acute thrombosis of the left superficial femoral artery, including the newly placed eluvia drug-eluting stents.In response to the event, suction thrombectomy was performed following which superficial femoral artery, including the eluvia drug-eluting stents were realigned by placement of a 6 mm x 250 mm and 6 mm x 10 mm self-expanding non-bsc covered stents to exclude thrombus from the flow channel.Post dilation of stents were performed using 6mm ranger drug coated balloon.Additionally, stenosis noted in the left popliteal artery was treated by drug coated balloon angioplasty using a 5 mm and 6 mm ranger drug coated balloons.Post procedure, angiography performed revealed patency of the left femoral and popliteal arteries with preserved runoff.On (b)(6) 2023, the event was considered to be resolved.

Manufacturer Narrative

A1 - patient identifier:(b)(6).A2 - age at time of event: the subject was 64 years old at the time of study enrollment.

Event Description

S2444 elegance.It was reported that the subject experienced acute thrombosis of the left superficial femoral artery (sfa), including the newly placed eluvia drug-eluting stents, during the index procedure.The subject underwent treatment with the ranger drug coated balloons and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left proximal and distal sfa, with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 5 mm.The target lesion was 200 mm long and 100% stenosed and was thus classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using 4.0 mm x 220 mm sterling pta balloon.Following pre-dilation, the target lesion experienced recoiling.Treatment of target lesion was performed by placement of two 6 mm x 120 mm eluvia drug eluting stents.Post target lesion treatment, 6 mm x 250 mm and 6 mm x 100 mm non-bsc stent graft stents was placed.Following post-dilation ranger drug coated balloons of sizes 5 mm x 200 mm and 6 mm x 200 mm, the final residual stenosis was noted to be 30%.On (b)(6) 2023, during the index procedure, intra-op angiography performed revealed acute thrombosis of the left superficial femoral artery, including the newly placed eluvia drug-eluting stents.In response to the event, suction thrombectomy was performed following which superficial femoral artery, including the eluvia drug-eluting stents were realigned by placement of a 6 mm x 250 mm and 6 mm x 10 mm self-expanding non-bsc covered stents to exclude thrombus from the flow channel.Post dilation of stents were performed using 6mm ranger drug coated balloon.Additionally, stenosis noted in the left popliteal artery was treated by drug coated balloon angioplasty using a 5 mm and 6 mm ranger drug coated balloons.Post procedure, angiography performed revealed patency of the left femoral and popliteal arteries with preserved runoff.On (b)(6) 2023, the event was considered to be resolved.It was further reported that the actual location of the target lesion during the index procedure was isolated to only the left distal sfa.During the index procedure, in addition to the previously reported target lesion, a second target lesion (002) was in the left proximal popliteal artery, left mid popliteal artery, left distal popliteal artery with 5 mm proximal reference vessel diameter and 4.5 mm distal reference vessel diameter.The second target lesion had a lesion length of 200 mm and was 90% stenosed, and was thus classified as tasc ii c lesion.Treatment of target lesion was performed by dilation using study devices of size 5 mm x 200 mm and 6 mm x 200 mm ranger drug coated balloons.Following treatment, the final residual stenosis was noted to be 20%.Additionally, although it was previously reported that ranger drug coated balloons of sizes 5 mm x 200 mm and 6 mm x 200 mm were used to post-dilate the first target lesion, further information revealed that this was not the case.

Manufacturer Narrative

A1 - patient identifier: subject (b)(6).A2 - age at time of event: the subject was 64 years old at the time of study enrollment.Updated fields: b5 - describe event or problem.

Event Description

S2444 elegance.It was reported that the subject experienced acute thrombosis of the left superficial femoral artery (sfa), including the newly placed eluvia drug-eluting stents, during the index procedure.The subject underwent treatment with the ranger drug coated balloons and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left proximal and distal sfa, with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 5 mm.The target lesion was 200 mm long and 100% stenosed and was thus classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using 4.0 mm x 220 mm sterling pta balloon.Following pre-dilation, the target lesion experienced recoiling.Treatment of target lesion was performed by placement of two 6 mm x 120 mm eluvia drug eluting stents.Post target lesion treatment, 6 mm x 250 mm and 6 mm x 100 mm non-bsc stent graft stents was placed.Following post-dilation ranger drug coated balloons of sizes 5 mm x 200 mm and 6 mm x 200 mm, the final residual stenosis was noted to be 30%.On (b)(6) 2023, during the index procedure, intra-op angiography performed revealed acute thrombosis of the left superficial femoral artery, including the newly placed eluvia drug-eluting stents.In response to the event, suction thrombectomy was performed following which superficial femoral artery, including the eluvia drug-eluting stents were realigned by placement of a 6 mm x 250 mm and 6 mm x 10 mm self-expanding non-bsc covered stents to exclude thrombus from the flow channel.Post dilation of stents were performed using 6mm ranger drug coated balloon.Additionally, stenosis noted in the left popliteal artery was treated by drug coated balloon angioplasty using a 5 mm and 6 mm ranger drug coated balloons.Post procedure, angiography performed revealed patency of the left femoral and popliteal arteries with preserved runoff.On (b)(6) 2023, the event was considered to be resolved.It was further reported that the actual location of the target lesion during the index procedure was isolated to only the left distal sfa.During the index procedure, in addition to the previously reported target lesion, a second target lesion (002) was in the left proximal popliteal artery, left mid popliteal artery, left distal popliteal artery with 5 mm proximal reference vessel diameter and 4.5 mm distal reference vessel diameter.The second target lesion had a lesion length of 200 mm and was 90% stenosed, and was thus classified as tasc ii c lesion.Treatment of target lesion was performed by dilation using study devices of size 5 mm x 200 mm and 6 mm x 200 mm ranger drug coated balloons.Following treatment, the final residual stenosis was noted to be 20%.Additionally, although it was previously reported that ranger drug coated balloons of sizes 5 mm x 200 mm and 6 mm x 200 mm were used to post-dilate the first target lesion, further information revealed that this was not the case.It was further reported that target lesion (001) during the index procedure was located in the left mid sfa extending up to left distal sfa.

Manufacturer Narrative

A1 - patient identifier: subject (b)(6).A2 - age at time of event: the subject was 64 years old at the time of study enrollment.

• 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: 17545436
• MDR Text Key: 321185401
• Report Number: 2124215-2023-43371
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• 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
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028631845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4.0 MM X 220 MM STERLING PTA BALLOON; 4.0 MM X 220 MM STERLING PTA BALLOON; 4.0 MM X 220 MM STERLING PTA BALLOON; 5 MM RANGER DRUG-COATED BALLOON; 5 MM RANGER DRUG-COATED BALLOON; 5 MM RANGER DRUG-COATED BALLOON; 6 MM RANGER DRUG-COATED BALLOON; 6 MM RANGER DRUG-COATED BALLOON; 6 MM RANGER DRUG-COATED BALLOON; 6 MM X 120 MM ELUVIA DRUG ELUTING STENT; 6 MM X 120 MM ELUVIA DRUG ELUTING STENT; 6 MM X 120 MM ELUVIA DRUG ELUTING STENT
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: Black Or African American