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 Muscle Weakness (1967); Pain (1994); Numbness (2415); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier - (b)(6).A2: age at time of event - 69 years old at the time of study enrollment.

Event Description

Elegance clinical study.It was reported that re-occlusion occurred.The subject underwent treatment with the 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), left mid sfa extending up to left distal sfa with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length of 240 mm and 100% stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 300 mm non-boston scientific balloon catheter and 5 mm x 220 mm and 6 mm x 220 mm non-boston scientific balloon catheters.Treatment of target lesion was performed by the placement of 6 mm x 120 mm eluvia drug eluting stent study device.Following post dilation with 6 mm x 220 mm non-boston scientific balloon catheter, the final residual stenosis was noted to be 0%.Residual stenosis was noted during index procedure and in response bailout stent was used to resolve the complication.On (b)(6) 2022, the subject was discharged from hospital on clopidogrel.On (b)(6) 2023, the subject was noted with the symptoms related to lower extremity arteriosclerosis obliteration and was hospitalized for further evaluation and treatment on the same day.On (b)(6) 2023, 220 days post index procedure, occlusion noted in the left mid sfa and left distal sfa was treated with percutaneous transluminal angioplasty and drug coated balloon angioplasty.Post treatment, final residual stenosis was noted to be 0%.On (b)(6) 2023, the event was considered resolved and the subject was discharged from the hospital on the same day.

Manufacturer Narrative

A1: patient identifier - (b)(6).A2: age at time of event - (b)(6) years old at the time of study enrollment.

Event Description

Elegance clinical study it was reported that re-occlusion occurred.The subject underwent treatment with the 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), left mid sfa extending up to left distal sfa with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length of 240 mm and 100% stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 300 mm non-boston scientific balloon catheter and 5 mm x 220 mm and 6 mm x 220 mm non-boston scientific balloon catheters.Treatment of target lesion was performed by the placement of 6 mm x 120 mm eluvia drug eluting stent study device.Following post dilation with 6 mm x 220 mm non-boston scientific balloon catheter, the final residual stenosis was noted to be 0%.Residual stenosis was noted during index procedure and in response bailout stent was used to resolve the complication.On (b)(6) 2022, the subject was discharged from hospital on clopidogrel.On (b)(6) 2023, the subject was noted with the symptoms related to lower extremity arteriosclerosis obliteration and was hospitalized for further evaluation and treatment on the same day.On (b)(6) 2023, 220 days post index procedure, occlusion noted in the left mid sfa and left distal sfa was treated with percutaneous transluminal angioplasty and drug coated balloon angioplasty.Post treatment, final residual stenosis was noted to be 0%.On (b)(6) 2023, the event was considered resolved and the subject was discharged from the hospital on the same day.It was further reported that the bailout stent used during the index procedure was the 6 mm x 120 mm eluvia drug-eluting study stent.On (b)(6) 2023, the subject visited the hospital with the symptoms related to intermittent claudication for 4 months and was hospitalized for further evaluation and treatment on the same day.On the same day, the subject stated that he was experiencing left calf pain, asthenia, with numbness and coldness of the left dorsum of foot during walking about 50 m and the symptoms would be relieved after resting for more than 10 min and the subject could continue walking.On (b)(6) 2023, lower limb ct angiography and ultrasound of left femoral artery showed stent occlusion.On (b)(6) 2023, 220 days post index procedure, thrombotic occlusion noted in the left mid sfa and left distal sfa were treated with percutaneous peripheral arterial thrombectomy using a non-boston scientific thrombus suction device followed by pre-dilation that was performed using a 4 mm x 220 mm non-boston scientific balloon, followed by a 5 mm x 150 mm balloon and a 6 mm x 220 mm balloon.Post treatment, final residual stenosis was noted to be 0%.During post procedure angiography, local non-flow-limiting dissections were noted, and the protective umbrella placed in the popliteal artery before the procedure was evacuated.Another angiography was performed which showed no obstruction.On (b)(6) 2023, the subject symptoms post procedure were improved, and the event was considered resolved and the subject was discharged from the hospital on the same day.

Event Description

Elegance clinical study.It was reported that re-occlusion occurred.The subject underwent treatment with the 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), left mid sfa extending up to left distal sfa with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length of 240 mm and 100% stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 300 mm non-boston scientific balloon catheter and 5 mm x 220 mm and 6 mm x 220 mm non-boston scientific balloon catheters.Treatment of target lesion was performed by the placement of 6 mm x 120 mm eluvia drug eluting stent study device.Following post dilation with 6 mm x 220 mm non-boston scientific balloon catheter, the final residual stenosis was noted to be 0%.Residual stenosis was noted during index procedure and in response bailout stent was used to resolve the complication.On (b)(6) 2022, the subject was discharged from hospital on clopidogrel.On (b)(6) 2023, the subject was noted with the symptoms related to lower extremity arteriosclerosis obliteration and was hospitalized for further evaluation and treatment on the same day.On (b)(6) 2023, 220 days post index procedure, occlusion noted in the left mid sfa and left distal sfa was treated with percutaneous transluminal angioplasty and drug coated balloon angioplasty.Post treatment, final residual stenosis was noted to be 0%.On (b)(6) 2023, the event was considered resolved and the subject was discharged from the hospital on the same day.It was further reported that the bailout stent used during the index procedure was the 6 mm x 120 mm eluvia drug-eluting study stent.On (b)(6) 2023, the subject visited the hospital with the symptoms related to intermittent claudication for 4 months and was hospitalized for further evaluation and treatment on the same day.On the same day, the subject stated that he was experiencing left calf pain, asthenia, with numbness and coldness of the left dorsum of foot during walking about 50 m and the symptoms would be relieved after resting for more than 10 min and the subject could continue walking.On (b)(6) 2023, lower limb ct angiography and ultrasound of left femoral artery showed stent occlusion.On (b)(6) 2023, 220 days post index procedure, thrombotic occlusion noted in the left mid sfa and left distal sfa were treated with percutaneous peripheral arterial thrombectomy using a non-boston scientific thrombus suction device followed by pre-dilation that was performed using a 4 mm x 220 mm non-boston scientific balloon, followed by a 5 mm x 150 mm balloon and a 6 mm x 220 mm balloon.Post treatment, final residual stenosis was noted to be 0%.During post procedure angiography, local non-flow-limiting dissections were noted, and the protective umbrella placed in the popliteal artery before the procedure was evacuated.Another angiography was performed which showed no obstruction.On (b)(6) 2023, the subject symptoms post procedure were improved, and the event was considered resolved and the subject was discharged from the hospital on the same day.It was further reported that the target lesion did not include the proximal sfa.The eluvia stent was implanted in the mid to distal sfa.

Manufacturer Narrative

A1: patient identifier - (b)(6).A2: age at time of event - 69 years old at the time of study enrollment.

• 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: 17031683
• MDR Text Key: 316295223
• Report Number: 2124215-2023-27268
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028123265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: Asian