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); Numbness (2415); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 09/08/2023

Event Type  Injury  

Event Description

Elegance clinical study: it was reported that a second occurrence of in-stent restenosis occurred, requiring intervention.On (b)(6) 2022, the subject underwent treatment with the eluvia drug eluting stent as a part of the elegance clinical trial.The 90% stenosed target lesion was located in the left distal superficial femoral artery (sfa) with 6.0 mm proximal reference vessel diameter, and 6.5 mm distal reference vessel diameter.The lesion length was 150 mm and was classified as transatlantic intersociety consensus (tasc) ii b lesion.Prior to target lesion treatment with the study device, lithotripsy was performed.Treatment of the target lesion was then performed by placement of this 6x120, 130 cm eluvia drug-eluting vascular stent system study device.Post treatment was performed using a lithotripsy device and the final residual stenosis was noted to be 20%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited the hospital for follow up lower extremity duplex ultrasound examination which revealed 50-75% stenosis in the left profunda femoral artery, greater than 75% stenosis in the ostial femoral artery, a patent left femoral artery stent with elevated velocities consistent with 50-75% stenosis in the distal segment and mild elevated velocities in left proximal popliteal artery.Left ankle brachial index was noted to be mildly reduced at rest.On (b)(6) 2023, the subject visited the hospital with complaints of left calf pain with ambulation; however, no action was taken at that time.On (b)(6) 2023, the subject revisited the hospital with complaints of left calf and groin/hip discomfort with short ambulation; however, no ulcers or rest pain were noted.Based on the findings, the subject was planned for angiography and peripheral vascular intervention.On (b)(6) 2023, the subject visited the hospital for planned angiogram with possible intervention.Angiography revealed a patent common iliac artery, 70% calcification of the left common femoral artery, patent profunda femoris artery, 75% stenosis in the proximal sfa with 70% in-stent restenosis of the distal sfa (target lesion) due to deep wall calcification and stent elongation, 60-70% stenosis in the popliteal artery, occlusion of the distal posterior tibial artery, and patent anterior tibial and peroneal arteries.On the same day, the 70% in-stent restenosis noted in the left distal superficial femoral artery was treated by lithotripsy followed by balloon dilation using a non-boston scientific balloon and 6 mm x 150 mm ranger drug-coated balloon.Post procedure, the final residual stenosis was noted to be 20%.On the same day, 70% stenosis was noted in left common femoral artery and was treated with a non-boston scientific medical balloon and dilation using a 7 mm x 60 mm ranger drug coated balloon with residual stenosis of less than 20%.Subsequently, 75% stenosis was noted in the left ostial superficial femoral artery and was treated with 6 mm x 40 mm ranger drug coated balloon with residual stenosis of 15%.Additionally, 60-70% stenosis was noted in the left proximal popliteal artery and was treated with 6 mm x 150 mm ranger drug coated balloon.Repeat angiogram was performed and revealed contrast extravasation in the proximal popliteal artery which was treated with balloon angioplasty.Repeat angiography revealed persisting extravasation which was sealed with reinflation of balloon for 10 minutes and the final residual stenosis was noted to be less than 30%.On the same day the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2023, the subject visited the emergency department with complaints of sudden onset of left calf and foot pain with numbness.Physical examination revealed left foot coolness, and absent left foot pulses.Subsequently, the subject underwent left lower extremity arterial duplex scanning which revealed a functionally occluded sfa stent, occlusion of the sfa distal to the stent, and an occluded anterior tibial artery.Additionally, the left ankle brachial index measured 0.60 at rest.Based in these findings, the subject was admitted to the hospital for peripheral angiogram and likely thrombolysis.On (b)(6) 2023, selective lower extremity angiogram was performed which revealed left mid-sfa occlusion which was treated with thrombolysis.On (b)(6) 2023, selective left lower extremity angiogram revealed persistent in-stent restenosis in the left distal sfa, limited contained extravasation of the left above knee popliteal artery with p3 popliteal artery and occluded posterior tibial artery.On the same day, in-stent occlusion was noted in the left distal sfa and was treated with intravascular lithotripsy followed by balloon dilation using a non-boston scientific balloon.Repeat angiography was performed and revealed greater than 50% stenosis which was treated by balloon dilation using a non-boston scientific balloon.Re-angiogram revealed persistent greater than 50% stenosis due to eccentric compressed lumen as a consequence of deep wall calcification.Additionally, on the same day, a dissection flap was noted in the left above knee popliteal artery and was treated with intravascular lithotripsy followed by placement of a non-boston scientific stent which was post dilated using a non-boston scientific balloon with sealing of the contained extravasation.On the same day, the event was considered to be resolved.On (b)(6) 2023, physical examination and doppler ultrasound revealed left foot pulses, and the subject was discharged from the hospital on clopidogrel.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: patient age: 65 years old at time of enrollment.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: patient age: 65 years old at time of enrollment.

Event Description

Elegance clinical study.It was reported that a second occurrence of in-stent restenosis occurred, requiring intervention.On (b)(6) 2022, the subject underwent treatment with the eluvia drug eluting stent as a part of the elegance clinical trial.The 90% stenosed target lesion was located in the left distal superficial femoral artery (sfa) with 6.0 mm proximal reference vessel diameter, and 6.5 mm distal reference vessel diameter.The lesion length was 150 mm and was classified as transatlantic intersociety consensus (tasc) ii b lesion.Prior to target lesion treatment with the study device, lithotripsy was performed.Treatment of the target lesion was then performed by placement of this 6x120, 130 cm eluvia drug-eluting vascular stent system study device.Post treatment was performed using a lithotripsy device and the final residual stenosis was noted to be 20%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited the hospital for follow up lower extremity duplex ultrasound examination which revealed 50-75% stenosis in the left profunda femoral artery, greater than 75% stenosis in the ostial femoral artery, a patent left femoral artery stent with elevated velocities consistent with 50-75% stenosis in the distal segment and mild elevated velocities in left proximal popliteal artery.Left ankle brachial index was noted to be mildly reduced at rest.On (b)(6) 2023, the subject visited the hospital with complaints of left calf pain with ambulation; however, no action was taken at that time.On (b)(6) 2023, the subject revisited the hospital with complaints of left calf and groin/hip discomfort with short ambulation; however, no ulcers or rest pain were noted.Based on the findings, the subject was planned for angiography and peripheral vascular intervention.On (b)(6) 2023, the subject visited the hospital for planned angiogram with possible intervention.Angiography revealed a patent common iliac artery, 70% calcification of the left common femoral artery, patent profunda femoris artery, 75% stenosis in the proximal sfa with 70% in-stent restenosis of the distal sfa (target lesion) due to deep wall calcification and stent elongation, 60-70% stenosis in the popliteal artery, occlusion of the distal posterior tibial artery, and patent anterior tibial and peroneal arteries.On the same day, the 70% in-stent restenosis noted in the left distal superficial femoral artery was treated by lithotripsy followed by balloon dilation using a non-boston scientific balloon and 6 mm x 150 mm ranger drug-coated balloon.Post procedure, the final residual stenosis was noted to be 20%.On the same day, 70% stenosis was noted in left common femoral artery and was treated with a non-boston scientific medical balloon and dilation using a 7 mm x 60 mm ranger drug coated balloon with residual stenosis of less than 20%.Subsequently, 75% stenosis was noted in the left ostial superficial femoral artery and was treated with 6 mm x 40 mm ranger drug coated balloon with residual stenosis of 15%.Additionally, 60-70% stenosis was noted in the left proximal popliteal artery and was treated with 6 mm x 150 mm ranger drug coated balloon.Repeat angiogram was performed and revealed contrast extravasation in the proximal popliteal artery which was treated with balloon angioplasty.Repeat angiography revealed persisting extravasation which was sealed with reinflation of balloon for 10 minutes and the final residual stenosis was noted to be less than 30%.On the same day the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2023, the subject visited the emergency department with complaints of sudden onset of left calf and foot pain with numbness.Physical examination revealed left foot coolness, and absent left foot pulses.Subsequently, the subject underwent left lower extremity arterial duplex scanning which revealed a functionally occluded sfa stent, occlusion of the sfa distal to the stent, and an occluded anterior tibial artery.Additionally, the left ankle brachial index measured 0.60 at rest.Based in these findings, the subject was admitted to the hospital for peripheral angiogram and likely thrombolysis.On (b)(6) 2023, selective lower extremity angiogram was performed which revealed left mid-sfa occlusion which was treated with thrombolysis.On (b)(6) 2023, selective left lower extremity angiogram revealed persistent in-stent restenosis in the left distal sfa, limited contained extravasation of the left above knee popliteal artery with p3 popliteal artery and occluded posterior tibial artery.On the same day, in-stent occlusion was noted in the left distal sfa and was treated with intravascular lithotripsy followed by balloon dilation using a non-boston scientific balloon.Repeat angiography was performed and revealed greater than 50% stenosis which was treated by balloon dilation using a non-boston scientific balloon.Re-angiogram revealed persistent greater than 50% stenosis due to eccentric compressed lumen as a consequence of deep wall calcification.Additionally, on the same day, a dissection flap was noted in the left above knee popliteal artery and was treated with intravascular lithotripsy followed by placement of a non-boston scientific stent which was post dilated using a non-boston scientific balloon with sealing of the contained extravasation.On the same day, the event was considered to be resolved.On (b)(6) 2023, physical examination and doppler ultrasound revealed left foot pulses, and the subject was discharged from the hospital on clopidogrel.It was further reported that on (b)(6) 2023, the previously reported selective lower extremity angiogram revealed mid-sfa occlusion with re-constitution in the distal sfa approximately 2 to 3 cm below the stent edge.On the same day, the mid-sfa and distal sfa in-stent occlusion were treated with thrombolysis.

• 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: 18088400
• MDR Text Key: 327586328
• Report Number: 2124215-2023-60351
• 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
• Report Date: 12/11/2023

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: 02/08/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028904689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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