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)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6), age at time of event- 56 years, initial reporter facility name: (b)(6) medical center.

Event Description

Elegance study: it was reported that an occlusion occurred.The subject underwent treatment with eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), mid sfa and distal sfa with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm with lesion length of 310 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment, pre dilation was performed with 5 mm x 250 mm non-boston scientific percutaneous angioplasty (pta) balloon, 5 mm x 120 mm and 4 mm x 60 mm non-boston scientific pta balloon, 4 mm x 150 mm non-boston scientific pta balloon, 2 mm x 30 mm and 4 mm x 30 mm non-boston scientific drug coated balloon and 5 mm x 120 mm non-boston scientific pta balloon.Treatment of target lesion was performed by placement of study devices, two 6 mm x 120 mm and one 6 mm x 80 mm eluvia drug-eluting stent.Following post dilation with 6 mm x 200 mm non-boston scientific pta balloon and 6 mm x 60 mm sterling balloon, the final residual stenosis was noted to be 15%.On the same day, the subject was discharged with clopidogrel and aspirin.On (b)(6) 2022, subject was experienced with the symptoms related to severe left lower extremity lifestyle limiting claudication and rest pain with left toe ulcer.On (b)(6) 2022, subject visited the hospital for the 6-month study specific follow up with complaints of lifestyle limiting claudication and rest pain with left toe ulcer.Subsequently on the same day bilateral lower extremity arterial doppler ultrasound was performed, which revealed total occlusion of left leg sfa stent and low volume/low velocity below knee arterial waveforms.On (b)(6) 2022, subject revisited the hospital for planned angiography with possible intervention for further evaluation and management of lifestyle limiting claudication (rutherford category: iv).Subsequently, left lower extremity angiography was performed which revealed a patent common iliac artery, external iliac artery, internal iliac artery, common femoral artery, profunda femoris artery, complete thrombotic occlusion of sfa study stents, patent popliteal artery and tibioperoneal trunk, chronic total occlusion of mid anterior tibial artery with distal collateral reconstitution, cto of distal peroneal artery with collateral reconstitution and patent posterior tibial artery.On (b)(6) 2022, 216 days post index procedure, thrombotic occlusion noted in left superficial femoral artery was treated by thrombolysis using 20 mg direct intra-arterial tissue plasminogen activator injection, followed by angioplasty using 5 mm x 300 mm non-boston scientific balloon along with directional atherectomy.In addition, balloon angioplasty with 5 mm x 250 mm and 6 mm x 120 mm non-boston scientific drug-coated balloon was performed in left mid to distal sfa and proximal sfa respectively, and two 6 mm x 40 mm eluvia drug-eluting stents were placed in proximal and distal sfa, respectively.Post-dilation with 6 mm x 40 mm non-boston scientific pta balloon and the final residual stenosis was noted to be 15%.Post procedure, peripheral pulses were noted be right dorsalis pedis (dp): +2/posterior tibial (pt): +1 and left dorsalis pedis (dp): +1 /posterior tibial (pt): +1.On the same day, the event was considered to be resolved and the subject was recommended to continue dual antiplatelet therapy.

Event Description

Elegance study it was reported that an occlusion occurred.The subject underwent treatment with eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), mid sfa and distal sfa with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm with lesion length of 310 mm and 100 % stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment, pre dilation was performed with 5 mm x 250 mm non-boston scientific percutaneous angioplasty (pta) balloon, 5 mm x 120 mm and 4 mm x 60 mm non-boston scientific pta balloon, 4 mm x 150 mm non-boston scientific pta balloon, 2 mm x 30 mm and 4 mm x 30 mm non-boston scientific drug coated balloon and 5 mm x 120 mm non-boston scientific pta balloon.Treatment of target lesion was performed by placement of study devices, two 6 mm x 120 mm and one 6 mm x 80 mm eluvia drug-eluting stent.Following post dilation with 6 mm x 200 mm non-boston scientific pta balloon and 6 mm x 60 mm sterling balloon, the final residual stenosis was noted to be 15%.On the same day, the subject was discharged with clopidogrel and aspirin.On 25-apr-2022, subject was experienced with the symptoms related to severe left lower extremity lifestyle limiting claudication and rest pain with left toe ulcer.On 03-may-2022, subject visited the hospital for the 6-month study specific follow up with complaints of lifestyle limiting claudication and rest pain with left toe ulcer.Subsequently on the same day bilateral lower extremity arterial doppler ultrasound was performed, which revealed total occlusion of left leg sfa stent and low volume/low velocity below knee arterial waveforms.On 12-may-2022, subject revisited the hospital for planned angiography with possible intervention for further evaluation and management of lifestyle limiting claudication (rutherford category: iv).Subsequently, left lower extremity angiography was performed which revealed a patent common iliac artery, external iliac artery, internal iliac artery, common femoral artery, profunda femoris artery, complete thrombotic occlusion of sfa study stents, patent popliteal artery and tibioperoneal trunk, chronic total occlusion of mid anterior tibial artery with distal collateral reconstitution, cto of distal peroneal artery with collateral reconstitution and patent posterior tibial artery.On 12-may-2022, 216 days post index procedure, thrombotic occlusion noted in left superficial femoral artery was treated by thrombolysis using 20 mg direct intra-arterial tissue plasminogen activator injection, followed by angioplasty using 5 mm x 300 mm non-boston scientific balloon along with directional atherectomy.In addition, balloon angioplasty with 5 mm x 250 mm and 6 mm x 120 mm non-boston scientific drug-coated balloon was performed in left mid to distal sfa and proximal sfa respectively, and two 6 mm x 40 mm eluvia drug-eluting stents were placed in proximal and distal sfa, respectively.Post-dilation with 6 mm x 40 mm non-boston scientific pta balloon and the final residual stenosis was noted to be 15%.Post procedure, peripheral pulses were noted be right dorsalis pedis (dp): +2/posterior tibial (pt): +1 and left dorsalis pedis (dp): +1 /posterior tibial (pt): +1.On the same day, the event was considered to be resolved and the subject was recommended to continue dual antiplatelet therapy.It was further reported that the subject underwent treatment with eluvia drug eluting stent on 08-oct-2021 as a part of the elegance clinical trial.The target lesion was classified as a tasc ii c lesion.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2: age at time of event- 56 years.E1 - initial reporter facility name: (b)(6).

• 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: 14632304
• MDR Text Key: 293545601
• Report Number: 2134265-2022-06388
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876595
• UDI-Public: 08714729876595
• 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: 07/28/2022

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: 04/16/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027302966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White