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 Problems Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 01/17/2023

Event Type  Injury  

Event Description

S2444 elegance it was reported that the subject experienced left superficial femoral artery (sfa) and popliteal artery re-occlusion post index procedure.On (b)(6) 2022, the subject underwent treatment with two ranger drug-coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the left proximal sfa, left mid sfa, left distal sfa, left proximal popliteal artery, left mid popliteal artery, and left distal popliteal artery.The target lesion had a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm, with a lesion length of 470 mm.The lesion was reported to be 100 percent stenosed and was classified as a tasc ii d lesion.Prior to target lesion treatment with the study devices, an atherectomy was performed using a non-bsc atherectomy device followed by pre-dilation using three non-bsc balloons.Treatment of the target lesion was performed by using two 5 mm x 200 mm ranger drug-coated balloons and a 6 mm x 120 mm eluvia drug-eluting stent.The target lesion was post-dilated using a 5 mm x 100 mm sterling pta balloon.Final residual stenosis was noted to be 20 percent.The subject was discharged the following day on aspirin and clopidogrel.On (b)(6) 2023, subject was noted with symptoms of left lower extremity claudication and was hospitalized for further medical evaluation and intervention on the same day.On (b)(6) 2023, 86 days post index procedure, occlusion was noted in the left proximal sfa, mid sfa, distal sfa, proximal popliteal artery, mid popliteal artery and distal popliteal artery was treated with non-bsc intravascular lithotripsy balloon followed by the placement of drug eluting stent.The event was considered resolved the same day.There were no further reported patient complications.

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: the patient was 75 years old at the time of study enrollment.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 75 years old at the time of study enrollment.

Event Description

S2444 elegance.It was reported that the subject experienced left superficial femoral artery (sfa) and popliteal artery re-occlusion post index procedure.On (b)(6) 2022, the subject underwent treatment with two ranger drug-coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the left proximal sfa, left mid sfa, left distal sfa, left proximal popliteal artery, left mid popliteal artery, and left distal popliteal artery.The target lesion had a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm, with a lesion length of 470 mm.The lesion was reported to be 100 percent stenosed and was classified as a tasc ii d lesion.Prior to target lesion treatment with the study devices, an atherectomy was performed using a non-bsc atherectomy device followed by pre-dilation using three non-bsc balloons.Treatment of the target lesion was performed by using two 5 mm x 200 mm ranger drug-coated balloons and a 6 mm x 120 mm eluvia drug-eluting stent.The target lesion was post-dilated using a 5 mm x 100 mm sterling pta balloon.Final residual stenosis was noted to be 20 percent.The subject was discharged the following day on aspirin and clopidogrel.On (b)(6) 2023, subject was noted with symptoms of left lower extremity claudication and was hospitalized for further medical evaluation and intervention on the same day.On (b)(6) 2023, 86 days post index procedure, occlusion was noted in the left proximal sfa, mid sfa, distal sfa, proximal popliteal artery, mid popliteal artery and distal popliteal artery was treated with non-bsc intravascular lithotripsy balloon followed by the placement of drug eluting stent.The event was considered resolved the same day.There were no further reported patient complications.It was further reported that on (b)(6) 2023, subject was noted with symptoms of heaviness of the upper part of left leg from hip to knee related to claudication in the left lower extremities and was hospitalized for further medical evaluation on the same day.The same day, lower limb arterial duplex was performed which revealed occlusion in left proximal sfa, left mid sfa, left distal sfa, left popliteal artery, and left dorsalis pedis artery and the rutherford classification was category 4 ischemic rest pain.Furthermore, the drug eluting stent reported to be placed on (b)(6) 2023 was reported to be a non-bsc stent.Final residual stenosis following treatment on january 19, 2023, was noted to be 10%.On (b)(6) 2023, the subject was discharged from the hospital.

Event Description

(b)(6) elegance.It was reported that the subject experienced left superficial femoral artery (sfa) and popliteal artery re-occlusion post index procedure.On (b)(6) 2022 the subject underwent treatment with two ranger drug-coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the left proximal sfa, left mid sfa, left distal sfa, left proximal popliteal artery, left mid popliteal artery, and left distal popliteal artery.The target lesion had a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm, with a lesion length of 470 mm.The lesion was reported to be 100 percent stenosed and was classified as a tasc ii d lesion.Prior to target lesion treatment with the study devices, an atherectomy was performed using a non-bsc atherectomy device followed by pre-dilation using three non-bsc balloons.Treatment of the target lesion was performed by using two 5 mm x 200 mm ranger drug-coated balloons and a 6 mm x 120 mm eluvia drug-eluting stent.The target lesion was post-dilated using a 5 mm x 100 mm sterling pta balloon.Final residual stenosis was noted to be 20 percent.The subject was discharged the following day on aspirin and clopidogrel.On (b)(6) 2023, subject was noted with symptoms of left lower extremity claudication and was hospitalized for further medical evaluation and intervention on the same day.On (b)(6) 2023, 86 days post index procedure, occlusion was noted in the left proximal sfa, mid sfa, distal sfa, proximal popliteal artery, mid popliteal artery and distal popliteal artery was treated with non-bsc intravascular lithotripsy balloon followed by the placement of drug eluting stent.The event was considered resolved the same day.There were no further reported patient complications.It was further reported that on (b)(6) 2023, subject was noted with symptoms of heaviness of the upper part of left leg from hip to knee related to claudication in the left lower extremities and was hospitalized for further medical evaluation on the same day.The same day, lower limb arterial duplex was performed which revealed occlusion in left proximal sfa, left mid sfa, left distal sfa, left popliteal artery, and left dorsalis pedis artery and the rutherford classification was category 4 ischemic rest pain.Furthermore, the drug eluting stent reported to be placed on (b)(6) 2023 was reported to be a non-bsc stent.Final residual stenosis following treatment on (b)(6) 2023, was noted to be 10%.On (b)(6) 2023, the subject was discharged from the hospital.Although it was previously reported that the subject was discharged from the hospital on (b)(6) 2023, further information revealed that the actual date of release was (b)(6) 2023.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 75 years old at the time of study enrollment.

Manufacturer Narrative

A1 - patient identifier: (b)(6) a2 - age at time of event: the patient was 75 years old at the time of study enrollment.Updated fields: b5 - describe event or problem g1 - mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email.

Event Description

S2444 elegance it was reported that the subject experienced left superficial femoral artery (sfa) and popliteal artery re-occlusion post index procedure.On (b)(6) 2022, the subject underwent treatment with two ranger drug-coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the left proximal sfa, left mid sfa, left distal sfa, left proximal popliteal artery, left mid popliteal artery, and left distal popliteal artery.The target lesion had a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm, with a lesion length of 470 mm.The lesion was reported to be 100 percent stenosed and was classified as a tasc ii d lesion.Prior to target lesion treatment with the study devices, an atherectomy was performed using a non-bsc atherectomy device followed by pre-dilation using three non-bsc balloons.Treatment of the target lesion was performed by using two 5 mm x 200 mm ranger drug-coated balloons and a 6 mm x 120 mm eluvia drug-eluting stent.The target lesion was post-dilated using a 5 mm x 100 mm sterling pta balloon.Final residual stenosis was noted to be 20 percent.The subject was discharged the following day on aspirin and clopidogrel.On (b)(6) 2023, subject was noted with symptoms of left lower extremity claudication and was hospitalized for further medical evaluation and intervention on the same day.On (b)(6) 2023, 86 days post index procedure, occlusion was noted in the left proximal sfa, mid sfa, distal sfa, proximal popliteal artery, mid popliteal artery and distal popliteal artery was treated with non-bsc intravascular lithotripsy balloon followed by the placement of drug eluting stent.The event was considered resolved the same day.There were no further reported patient complications.It was further reported that on (b)(6) 2023, subject was noted with symptoms of heaviness of the upper part of left leg from hip to knee related to claudication in the left lower extremities and was hospitalized for further medical evaluation on the same day.The same day, lower limb arterial duplex was performed which revealed occlusion in left proximal sfa, left mid sfa, left distal sfa, left popliteal artery, and left dorsalis pedis artery and the rutherford classification was category 4 ischemic rest pain.Furthermore, the drug eluting stent reported to be placed on (b)(6) 2023 was reported to be a non-bsc stent.Final residual stenosis following treatment on (b)(6) 2023, was noted to be 10%.On (b)(6) 2023, the subject was discharged from the hospital.Although it was previously reported that the subject was discharged from the hospital on (b)(6) 2023, further information revealed that the actual date of release was (b)(6) 2023.It was further reported that post successful treatment of the left lower extremity on (b)(6) 2023, prior to discharge, the subject complained of recurrent pain and repeat imaging study showed re-occlusion of her left sfa and left popliteal artery.Hence, the subject was scheduled for peripheral angiography with pei if clinically indicated for limb preservation.On (b)(6) 2023, selective angiography of left lower extremity performed revealed patent left common femoral artery, totally occluded left sfa at the ostium, patent left deep femoral artery, totally occluded left popliteal artery, and totally occluded left anterior tibial artery in its proximal segment.On the same day, 91 days post index procedure, occlusion noted in the left proximal sfa, mid sfa, distal sfa, mid popliteal artery and distal popliteal artery were treated by mechanical aspiration thrombectomy using a non-bsc aspiration system followed by balloon angioplasty using cutting balloon and the placement of a non-bsc nitinol self-expanding drug eluting stent to the non-stented lesion in the left proximal sfa segment and the placement of a non-bsc nitinol self-expanding drug eluting stent to the stented distal popliteal artery segment.Post treatment, final residual stenosis was noted to be 5%.The same day, the event was considered resolved.

• 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: 16391933
• MDR Text Key: 309746020
• Report Number: 2124215-2023-07238
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028534299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/28/2023; 06/02/2023; 07/28/2023
• Supplement Dates FDA Received: 04/20/2023; 06/26/2023; 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: Black Or African American