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

Model Number	H74939294700410
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: patient age 60 years old (at the time of enrollment).
Event or Problem Description
It was reported via a clinical study that the stent was undersized in diameter, requiring intervention.On (b)(6) 2024, occlusion was noted in the left ostial superficial femoral artery (sfa) and was treated by dilation using 5 x 40 mm mustang percutaneous transluminal angioplasty balloon.Treatment was also performed for thrombotic occlusion in the left sfa and popliteal arteries by thrombectomy using penumbra lightning bolt catheter.Subsequently the distal aspect of the sfa stent was treated by balloon angioplasty using 5 x 150 mm sterling pta balloon, 6 x 150 mm ranger drug coated balloon.This was followed by placement of 7 x 40 mm eluvia drug eluting stent from the left distal common femoral artery and left ostial sfa, and the stent was post dilated using 6 x 40 mm mustang pta balloon.Post treatment, the final residual stenosis was noted to be 0%.Final angiograms demonstrate brisk flow through the stented segment with three-vessel runoff to the foot.On (b)(6) 2024, the event was considered to be resolved, and the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2024, the previously placed 7 x 40 mm eluvia drug eluting stent appeared to be undersized in diameter.On the same day, common femoral artery was treated by 7 x 100 mm mustang pta balloon, followed by placement of 9 x 100 mm epic self-expanding stent and post dilated using 8 x 60 mm mustang pta balloon with excellent results.On (b)(6) 2024, the event was considered resolved.On (b)(6) 2024, the subject was discharged from the hospital on clopidogrel.
Additional Manufacturer Narrative
A2: patient age 60 years old (at the time of enrollment).Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the stent was undersized in diameter, requiring intervention.On (b)(6) 2024, occlusion was noted in the left ostial superficial femoral artery (sfa) and was treated by dilation using 5 x 40 mm mustang percutaneous transluminal angioplasty balloon.Treatment was also performed for thrombotic occlusion in the left sfa and popliteal arteries by thrombectomy using penumbra lightning bolt catheter.Subsequently the distal aspect of the sfa stent was treated by balloon angioplasty using 5 x 150 mm sterling pta balloon, 6 x 150 mm ranger drug coated balloon.This was followed by placement of 7 x 40 mm eluvia drug eluting stent from the left distal common femoral artery and left ostial sfa, and the stent was post dilated using 6 x 40 mm mustang pta balloon.Post treatment, the final residual stenosis was noted to be 0%.Final angiograms demonstrate brisk flow through the stented segment with three-vessel runoff to the foot.On 22-nov-2024, the event was considered to be resolved, and the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2024, the previously placed 7 x 40 mm eluvia drug eluting stent appeared to be undersized in diameter.On the same day, common femoral artery was treated by 7 x 100 mm mustang pta balloon, followed by placement of 9 x 100 mm epic self-expanding stent and post dilated using 8 x 60 mm mustang pta balloon with excellent results.On 19-dec-2024, the event was considered resolved.On (b)(6) 2024, the subject was discharged from the hospital on clopidogrel.It was further reported that on (b)(6) 2024, the undersized stent was treated by 7 x 100 mm mustang pta balloon, followed by placement of 9 x 100 mm epic self-expanding stent and post dilated using 8 x 60 mm mustang pta balloon with excellent results.
Additional Manufacturer Narrative
A2: patient age 60 years old (at the time of enrollment).
Event or Problem Description
It was reported that the stent was undersized in diameter, requiring intervention.On (b)(6) 2024, occlusion was noted in the left ostial superficial femoral artery (sfa) and was treated by dilation using 5 x 40 mm mustang percutaneous transluminal angioplasty balloon.Treatment was also performed for thrombotic occlusion in the left sfa and popliteal arteries by thrombectomy using penumbra lightning bolt catheter.Subsequently the distal aspect of the sfa stent was treated by balloon angioplasty using 5 x 150 mm sterling pta balloon, 6 x 150 mm ranger drug coated balloon.This was followed by placement of 7 x 40 mm eluvia drug eluting stent from the left distal common femoral artery and left ostial sfa, and the stent was post dilated using 6 x 40 mm mustang pta balloon.Post treatment, the final residual stenosis was noted to be 0%.Final angiograms demonstrate brisk flow through the stented segment with three-vessel runoff to the foot.On (b)(6) 2024, the event was considered to be resolved, and the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2024, the previously placed 7 x 40 mm eluvia drug eluting stent appeared to be undersized in diameter.On the same day, common femoral artery was treated by 7 x 100 mm mustang pta balloon, followed by placement of 9 x 100 mm epic self-expanding stent and post dilated using 8 x 60 mm mustang pta balloon with excellent results.On (b)(6) 2024, the event was considered resolved.On (b)(6) 2024, the subject was discharged from the hospital on clopidogrel.It was further reported that on (b)(6) 2024, the undersized stent was treated by 7 x 100 mm mustang pta balloon, followed by placement of 9 x 100 mm epic self-expanding stent and post dilated using 8 x 60 mm mustang pta balloon with excellent results.

• Brand Name: ELUVIA?
• Common Device Name: 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: 22125710
• Report Number: 2124215-2025-33162
• Device Sequence Number: 7421780
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: (01)08714729876694(17)251204(10)33055836
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2025
• Device Model Number: H74939294700410
• Device Catalogue Number: H74939294700410
• Device Lot Number: 0033055836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 09/12/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/24/2025; 09/15/2025
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White