MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 07/02/2023

Event Type  Injury  

Manufacturer Narrative

Patient age: 65 years old at time of enrollment e1 initial reporter phone: (b)(6).

Event Description

Elegance clinical study it was reported that stent occlusion and thrombosis occurred, requiring medication and an additional device.On (b)(6) 2022, the subject underwent treatment with this 6x80, 130 cm eluvia drug-eluting vascular stent system as part of the elegance clinical trial.The 100% stenosed target lesion was located in the right mid-superficial femoral artery (sfa) extending up to the right distal sfa.There was a 6 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with a lesion length of 80 mm, and was classified as transatlantic intersociety consensus (tasc) ii b lesion.Prior to the treatment of the target lesion with the study device, pre-dilation was performed by using 4 mm x 80 mm and 5 mm x 80 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloons.Treatment of the target lesion was performed by the placement of this study device.Post-dilation was performed by using a 5 mm x 80 mm non-boston scientific pta balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) -2023, the subject was noted with symptoms related to thrombosis in the right lower extremity artery and was hospitalized on the same day for further evaluation and treatment.On the same day, right lower extremity angiography was performed.Occlusion was noted in the right mid-sfa and was treated by thrombolysis and percutaneous transluminal angioplasty.Post procedure, the final residual stenosis was noted to be 10%.On (b)(6) 2023, the event was resolved, and the subject was discharged from the hospital on the same day.

Manufacturer Narrative

A2: patient age: 65 years old at time of enrollment.E1 initial reporter phone: (b)(6).

Event Description

Elegance clinical study.It was reported that stent occlusion and thrombosis occurred, requiring medication and an additional device.On (b)(6) 2022, the subject underwent treatment with this 6x80, 130 cm eluvia drug-eluting vascular stent system as part of the elegance clinical trial.The 100% stenosed target lesion was located in the right mid-superficial femoral artery (sfa) extending up to the right distal sfa.There was a 6 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with a lesion length of 80 mm, and was classified as transatlantic intersociety consensus (tasc) ii b lesion.Prior to the treatment of the target lesion with the study device, pre-dilation was performed by using 4 mm x 80 mm and 5 mm x 80 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloons.Treatment of the target lesion was performed by the placement of this study device.Post-dilation was performed by using a 5 mm x 80 mm non-boston scientific pta balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject was noted with symptoms related to thrombosis in the right lower extremity artery and was hospitalized on the same day for further evaluation and treatment.On the same day, right lower extremity angiography was performed.Occlusion was noted in the right mid-sfa and was treated by thrombolysis and percutaneous transluminal angioplasty.Post procedure, the final residual stenosis was noted to be 10%.On (b)(6) 2023, the event was resolved, and the subject was discharged from the hospital on the same day.It was further reported that on (b)(6) 2023, the subject visited the hospital with a relapse of intermittent claudication of the right lower limb after discontinuing the antiplatelet medications due to gastro-intestinal hemorrhage.On the same day, duplex ultrasound examination was performed which revealed thrombosis in the right lower limb artery stent.As previously reported, the subject was then hospitalized for further evaluation and treatment of lower limb arterial thrombosis.Additionally, the previously reported angiogram of the right lower extremity also revealed an unobstructed common femoral artery, deep femoral artery, proximal and mid sfa; however, the original sfa stent was not developed and there were multiple mild to moderate stenoses in the mid and distal peroneal artery.On the same day, thrombotic occlusion in the right superficial femoral artery was treated by aspiration thrombectomy using 6f straub suction catheter.Re-angiography was performed which revealed an unobstructed sfa with residual stenosis; however, the distal peroneal artery was not developed due to embolization of thrombus to the proximal end of the peroneal artery.In response, aspiration thrombectomy was performed using a 5f suction catheter followed by dilation using 2 mm x 150 mm balloon.Re-angiography performed revealed occluded right sfa stent, due to elastic retraction of the stent content.Subsequently, occlusion noted in the original sfa stent was treated by dilation using 4 mm x 80 mm balloon followed by aspiration thrombectomy using a stream suction catheter.Post balloon dilation using 5 mm x 150 mm drug coated balloon, the final residual stenosis was noted to be 10%.On (b)(6) 2023, the subjects general condition was good, the color of the infrapopliteal skin of the right lower limb turned rosy and temperature was increased significantly.On (b)(6) 2023, the event was considered to be resolved, and on the same day, the subject was discharged from the hospital on dual antiplatelet therapy.

• 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: 17802246
• MDR Text Key: 324110208
• Report Number: 2124215-2023-50826
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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: 04/21/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027336945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: Asian