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 Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Unspecified Vascular Problem (4441)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

Elegance clinical trial.It was reported that claudication and occlusion occurred.The subject underwent treatment with ranger drug coated balloons (dcb) and eluvia drug eluting stent on (b)(6) 2022 as part of the elegance clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa), left proximal popliteal artery, mid popliteal artery extending to distal popliteal artery.The lesion had a proximal reference vessel diameter of 5mm, distal reference vessel diameter of 5mm, lesion length of 190mm, 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, a non boston scientific (bsc) embolization protection device was used and pre dilation was performed with a 5mm x 150mm and 4mm x 40mm non-bsc balloons.Treatment of target lesion was performed by the following ranger dcb study devices: 4mm x 40mm, 5mm x 200mm and 5mm x 60mm, respectively, followed by placement of a 6mm x 60mm eluvia drug eluting study stent.Following post dilation with 5mm x 20mm nc emerge balloon, the final residual stenosis was noted to be 30%.On (b)(6) 2022, the subject visited the hospital with symptoms related to claudication.Segmental pressure and pulse volume recording (pvr) study was performed, which revealed normal right ankle brachial index (abi) of 1.13 and obstructive peripheral arterial disease of left leg with abi of 0.47.On (b)(6) 2022, subject revisited the hospital with known severe residual disease with rutherford category 3 (severe claudication) and was referred for the lower extremity angiography with possible intervention.On the same day, angiography performed in the right lower extremity revealed tortuous mild diffuse disease in the common iliac artery, external iliac artery and internal iliac artery, calcified mild diffuse disease in common femoral artery and profunda femoris artery, patent stent with mild diffuse disease in sfa and popliteal femoral artery.Angiography performed in the left lower extremity also revealed tortuous mild diffuse disease in common iliac artery, external iliac artery and internal iliac artery, patent common femoral artery and profunda femoris artery, patent stent in proximal sfa, patent mid sfa stent with mild disease, occluded distal sfa and popliteal artery, occluded tibioperoneal trunk, anterior tibial artery and ostial posterior tibial artery.On (b)(6) 2022, 16 days post index procedure, occlusion noted in the left distal sfa and left popliteal artery was treated with a 3.00mm x 150mm non-bsc balloon, 5mm x 150mm non-bsc balloon, 4mm x 40mm non-bsc balloon followed by 6mm x 150mm ranger dcb.In addition, occlusion noted in tibioperoneal trunk was treated with placement of 4mm x 32mm synergy stent, followed by post dilation with 5.0mm x 20mm nc emerge balloon with excellent angiographic results.On (b)(6) 2022, the event was considered resolved.

Event Description

Elegance clinical trial it was reported that claudication and occlusion occurred.The subject underwent treatment with ranger drug coated balloons (dcb) and eluvia drug eluting stent on (b)(6) 2022 as part of the elegance clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa), left proximal popliteal artery, mid popliteal artery extending to distal popliteal artery.The lesion had a proximal reference vessel diameter of 5mm, distal reference vessel diameter of 5mm, lesion length of 190mm, 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, a non boston scientific (bsc) embolization protection device was used and pre dilation was performed with a 5mm x 150mm and 4mm x 40mm non-bsc balloons.Treatment of target lesion was performed by the following ranger dcb study devices: 4mm x 40mm, 5mm x 200mm and 5mm x 60mm, respectively, followed by placement of a 6mm x 60mm eluvia drug eluting study stent.Following post dilation with 5mm x 20mm nc emerge balloon, the final residual stenosis was noted to be 30%.On (b)(6) 2022, the subject visited the hospital with symptoms related to claudication.Segmental pressure and pulse volume recording (pvr) study was performed, which revealed normal right ankle brachial index (abi) of 1.13 and obstructive peripheral arterial disease of left leg with abi of 0.47.On 28-apr-2022, subject revisited the hospital with known severe residual disease with rutherford category 3 (severe claudication) and was referred for the lower extremity angiography with possible intervention.On the same day, angiography performed in the right lower extremity revealed tortuous mild diffuse disease in the common iliac artery, external iliac artery and internal iliac artery, calcified mild diffuse disease in common femoral artery and profunda femoris artery, patent stent with mild diffuse disease in sfa and popliteal femoral artery.Angiography performed in the left lower extremity also revealed tortuous mild diffuse disease in common iliac artery, external iliac artery and internal iliac artery, patent common femoral artery and profunda femoris artery, patent stent in proximal sfa, patent mid sfa stent with mild disease, occluded distal sfa and popliteal artery, occluded tibioperoneal trunk, anterior tibial artery and ostial posterior tibial artery.On (b)(6) 2022, 16 days post index procedure, occlusion noted in the left distal sfa and left popliteal artery was treated with a 3.00mm x 150mm non-bsc balloon, 5mm x 150mm non-bsc balloon, 4mm x 40mm non-bsc balloon followed by 6mm x 150mm ranger dcb.In addition, occlusion noted in tibioperoneal trunk was treated with placement of 4mm x 32mm synergy stent, followed by post dilation with 5.0mm x 20mm nc emerge balloon with excellent angiographic results.On (b)(6) 2022, the event was considered resolved.It was further reported that the patient was diagnosed with peripheral artery disease in the right leg.

Manufacturer Narrative

A1.Patient identifier: (b)(6).B5.Updated event description with additional information received.

• 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: 14639325
• MDR Text Key: 294840417
• Report Number: 2134265-2022-06512
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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: 0027799329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White