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); Ulcer (2274); Restenosis (4576)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age at time of enrollment: 84 years.

Event Description

It was reported that critical limb ischemia of the left lower extremity occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the left distal superficial femoral artery extending up to left proximal popliteal artery with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length 40 mm with 80% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, lithotripsy was performed by using 5.0 mm x 60 mm non-boston scientific (bsc) lithotripsy device.Treatment of target lesion was performed by dilation using study device, 5.0 mm x 200 mm ranger drug-coated balloon.Following post treatment was performed by the placement of 5.0 mm x 60 mm non-bsc bare metal stent, and the final residual stenosis was noted to be 20%.During the treatment of the first target lesion, dissection of grade b was noted due to lithotripsy device which was treated with placement of bare metal stent.The second target lesion was in the left mid superficial femoral artery with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length 120 mm with 80% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, lithotripsy was performed by using 5.0 mm x 60 mm non-bsc lithotripsy device.Treatment of target lesion was performed by dilation using study device, 5.0 mm x 200 mm ranger drug-coated balloon followed by the placement of study device, 6 mm x 40 mm eluvia drug eluting stent.Following treatment, the final residual stenosis was noted to be 20%.During the treatment of the second target lesion, dissection of grade b was noted due to lithotripsy device which was treated using placement of bailout stent.The third target lesion was in the left common femoral artery with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length 40 mm with 90% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, lithotripsy was performed by using 5.0 mm x 60 mm non-bsc lithotripsy device.Treatment of target lesion was performed by dilation using study device, 6.0 mm x 40 mm ranger drug-coated balloon.Following treatment, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject was presented to clinic with left toe blister.On (b)(6) 2023, left lower extremity arterial doppler examination revealed greater than 75% stenosis in the common femoral artery with post-stenotic turbulence, occluded sfa, popliteal artery, posterior tibial artery, anterior tibial artery and peroneal artery.On (b)(6) 2023, subject was evaluated for critical limb ischemia with left first toe ulcer and was started on cephalexin.On (b)(6) 2023, subject visited the hospital with complaints of small puss pocket in the left second toe and significant bilateral foot pain, worse on the left limb.On the same day, physical examination of left lower extremity revealed warm, erythema, shiny with peeling skin, purulent wound on great toe with tiny puss pocket on the lateral side of the tip of left second toe and discoloration.The rutherford classification assessed revealed category 4 ischemic rest pain.Based on the findings, subject was hospitalized for further treatment and was started on vancomycin, cefepime and flagyl and peripheral angiogram was scheduled on (b)(6)2023.On (b)(6) 2023, subject consulted the podiatry to assess the left great toe wound and was advised to continue cephalexin.On (b)(6) 2023, rutherford classification was noted to be category 5 critical limb ischemia with minor tissue loss and selective left lower extremity angiography performed revealed widely patent left common femoral artery and left profunda artery, occluded left superficial femoral artery and left popliteal artery, 90% stenosis in left proximal peroneal artery, occluded left anterior tibial artery, and left posterior artery.On (b)(6) 2023, 578 days post index procedure, occlusion noted in the left superficial femoral artery and left popliteal artery were treated using laser atherectomy followed by 4 mm x 150 mm balloon angioplasty and mechanical thrombectomy using non-bsc device.Subsequently, balloon dilation was performed using 5 mm x 200 mm and 6 mm x 200 mm ranger drug coated balloon followed by the placement of 6 mmx 250 mm non-bsc covered stent in the proximal and mid sfa.Post treatment, residual stenosis was noted to be less than 10%.Additionally, 90% stenosis noted in the left peroneal artery was treated with mechanical thrombectomy using non-bsc thrombectomy device followed by placement of 4 mm x 23 mm non-bsc drug eluting stent.Post treatment, residual stenosis was noted to be less than 10%.On the same day, the event was considered to be resolved.On (b)(6) 2023, subject consulted podiatry for possibly infected left distal hallux ulcer.Physical examination revealed barely palpable dp and pt pulses bilaterally, dry, hematogenous eschar at distal left hallux however, no expressible fluid noted.Subject was recommended to apply sterile wound dressing and cover the ulcer with a small silicone foam wound dressing pad to loosen up the eschar.On (b)(6) 2023, vancomycin, cefepime, flagyl was discontinued and subject was started on doxycycline and cefdinir for 4 days.On (b)(6) 2023, subject was discharged from the hospital to skilled nursing facility.

• 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: 18087307
• MDR Text Key: 327589057
• Report Number: 2124215-2023-60702
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027808709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: White