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 Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

A1 - patient identifier: (b)(6).A1 - age at time of event: the subject was 68 years old at the time of study enrollment.B3 - date of event: the event date is an estimate.The onset date of the symptoms related to necrosis was reported to be in (b)(6) 2023, after the subject previously was discharged on (b)(6) 2023.The exact onset date is unknown.E1 - initial report facility name: (b)(6) hospital.

Event Description

(b)(4) elegance clinical trial it was reported that the subject experienced necrosis of the right anterior foot and symptoms related to stent occlusion as a result of the index procedure and study device.On (b)(6) 2023, the subject underwent treatment with the eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery (sfa) extending up to right mid sfa.The target lesion had a proximal reference vessel diameter of 5.8 mm, a distal reference vessel diameter of 5.5 mm, and a lesion length of 120 mm.The target lesion was100% stenosed and was classified as a tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using a non-bsc percutaneous transluminal angioplasty (pta) balloon.Treatment of target lesion was performed by placement of the 6 mm x 120 mm eluvia drug eluting stent.Following stent placement, dilation was performed by using a non-bsc pta balloon.Following treatment, the final residual stenosis was noted to be 10%.On (b)(6) 2023, the subject was discharged on aspirin.On a later date in (b)(6) 2023, the subject developed symptoms related to necrosis of the right anterior foot.In response to the event, the subject was treated with medications.No further information was available.On (b)(6) 2023, subject was noted with symptoms related to stent occlusion.In response to the event, medication was given.No further information was available.

Event Description

S2444 elegance clinical trial.It was reported that the subject experienced necrosis of the right anterior foot and symptoms related to stent occlusion as a result of the index procedure and study device.On (b)(6) 2023 the subject underwent treatment with the eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery (sfa) extending up to right mid sfa.The target lesion had a proximal reference vessel diameter of 5.8 mm, a distal reference vessel diameter of 5.5 mm, and a lesion length of 120 mm.The target lesion was100% stenosed and was classified as a tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using a non-bsc percutaneous transluminal angioplasty (pta) balloon.Treatment of target lesion was performed by placement of the 6 mm x 120 mm eluvia drug eluting stent.Following stent placement, dilation was performed by using a non-bsc pta balloon.Following treatment, the final residual stenosis was noted to be 10%.On (b)(6) 2023 the subject was discharged on aspirin.On a later date in (b)(6) 2023 the subject developed symptoms related to necrosis of the right anterior foot.In response to the event, the subject was treated with medications.No further information was available.On (b)(6) 2023 subject was noted with symptoms related to stent occlusion.In response to the event, medication was given.No further information was available.It was further reported that at the end of (b)(6) 2023 subject had swelling and pain in the right foot accompanied by pus which was gradually aggravated to necrosis in the front of the right foot, and subject was unable to carry out off-bed activities.Additionally, on (b)(6) 2023 the subject presented for a scheduled 6-month follow up visit, per protocol.On the same day, the color doppler ultrasound examination of lower limb arteries performed revealed, no obvious blood flow signal in the sfa stent of the right lower limb.The possibility of stent occlusion was considered.The lower limb arteries showed intima media thickening with plaque formation.Rutherford classification assessed on the same day was 5 - minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema.The event was considered to be ongoing.No further patient complications were reported.

Manufacturer Narrative

A1 - patient identifier:(b)(6).A1 - age at time of event: the subject was 68 years old at the time of study enrollment.B3 - date of event: the event date is an estimate.The onset date of the symptoms related to necrosis was reported to be in (b)(6) 2023 after the subject previously was discharged on (b)(6) 2023.Th exact onset date is unknown.E1 - initial report 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; 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: 17088604
• MDR Text Key: 316855734
• Report Number: 2124215-2023-29255
• 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
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028793160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Race: Asian