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 Ischemia (1942); Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).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 lower extremity claudication and rest pain, left lower extremity critical limb ischemia, as well as left superficial femoral artery (sfa) and popliteal artery restenosis post index procedure.Additionally, the subject was diagnosed with an occlusion in the left sfa and popliteal artery post index procedure.Both events resulted in hospitalization and an additional 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) 2022, bilateral lower extremity arterial duplex was performed, occlusion was noted in right mid sfa, right dorsalis pedis artery as well as left proximal sfa, left mid sfa and left distal sfa, left popliteal artery, and left anterior tibial artery.On the same day, abi was assessed which revealed, right brachial systolic pressure 139 mmhg, right posterior tibial systolic pressure 90 mmhg, right dorsalis pedis systolic pressure 77 mmhg, left brachial systolic pressure 135 mmhg, left posterior tibial systolic pressure 63 mmhg, and left dorsalis pedis systolic pressure 0 mmhg.On (b)(6) 2023, the subject was noted with left lower extremity rest pain and claudication.On (b)(6) 2023, the subject visited the hospital and was hospitalized for further medical evaluation and intervention.On (b)(6) 2023, 80 days post index procedure, an occlusion was noted in the left proximal sfa, mid sfa, distal sfa, mid popliteal artery and distal popliteal artery.The occlusion was treated using a non-bsc intravascular lithotripsy balloon and a non-bsc paclitaxel drug coated balloon as definitive therapy followed by the placement of non-bsc stent and an unspecified nitinol self-expanding stent.Post treatment, the final residual stenosis was noted to be 20%.During the procedure of target lesion revascularization, residual stenosis of greater than 50% and flow-limiting dissection were noted in the left mid sfa and distal sfa.In response, two non-bsc self-expanding stents were successfully implanted.The event was considered resolved the same day.On (b)(6) 2023, the subject was discharged from the hospital.

Event Description

S2444 elegance.It was reported that the subject experienced left lower extremity claudication and rest pain, left lower extremity critical limb ischemia, as well as left superficial femoral artery (sfa) and popliteal artery restenosis post index procedure.Additionally, the subject was diagnosed with an occlusion in the left sfa and popliteal artery post index procedure.Both events resulted in hospitalization and an additional 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) 2022, bilateral lower extremity arterial duplex was performed, occlusion was noted in right mid sfa, right dorsalis pedis artery as well as left proximal sfa, left mid sfa and left distal sfa, left popliteal artery, and left anterior tibial artery.On the same day, abi was assessed which revealed, right brachial systolic pressure 139 mmhg, right posterior tibial systolic pressure 90 mmhg, right dorsalis pedis systolic pressure 77 mmhg, left brachial systolic pressure 135 mmhg, left posterior tibial systolic pressure 63 mmhg, and left dorsalis pedis systolic pressure 0 mmhg.On (b)(6) 2023, the subject was noted with left lower extremity rest pain and claudication.On (b)(6) 2023, the subject visited the hospital and was hospitalized for further medical evaluation and intervention.On (b)(6) 2023, 80 days post index procedure, an occlusion was noted in the left proximal sfa, mid sfa, distal sfa, mid popliteal artery and distal popliteal artery.The occlusion was treated using a non-bsc intravascular lithotripsy balloon and a non-bsc paclitaxel drug coated balloon as definitive therapy followed by the placement of non-bsc stent and an unspecified nitinol self-expanding stent.Post treatment, the final residual stenosis was noted to be 20%.During the procedure of target lesion revascularization, residual stenosis of greater than 50% and flow-limiting dissection were noted in the left mid sfa and distal sfa.In response, two non-bsc self-expanding stents were successfully implanted.The event was considered resolved the same day.On (b)(6) 2023, the subject was discharged from the hospital.It was further reported that the event term was updated to left lower extremity critical limb ischemia, excluding the previously reported event terms of left lower extremity claudication and rest pain, and left sfa and popliteal artery restenosis.

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.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16390113
• MDR Text Key: 309746817
• Report Number: 2124215-2023-05551
• 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
• Report Date: 04/20/2023

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: 01/18/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/20/2023
• 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
• Treatment: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: Black Or African American