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

Model Number	24657
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) clinical study.It was reported that stent damage occurred.The subject underwent treatment with eluvia drug-eluting stent treatment on (b)(6) 2021 as a part of the (b)(6) clinical trial.The target lesion #001 was in the right mid superficial femoral artery (sfa) with unknown proximal reference vessel diameter and unknown distal reference vessel diameter and 100% stenosis and tasc ii lesion classified as c.Prior to target lesion treatment, pre-dilatation was performed with a 6 mm x 150 mm non-boston scientific drug coated balloon.Treatment of the target lesion was performed by placement of study device, eluvia drug coated stent of 7.0 mm x 120 mm, 130cm followed by placement of 7.0 mm x 100 mm eluvia drug eluting stent.Post target lesion treatment was done with the non-boston scientific study device.Post treatment, the final residual stenosis was noted to be 10%.On (b)(6) 2021, during the index procedure, the 7x120, 130 cm eluvia drug eluting stent was difficult or unable to deploy in the target lesion and the 7.0 mm x 120 mm, 130cm eluvia drug eluting stent was damaged.In addition, during the index procedure, the 7x80, 130 cm eluvia drug eluting stent was damaged.No further action was taken.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12984552
• Report Number: 2134265-2021-15245
• Device Sequence Number: 5707228
• Product Code: NIU
• UDI-Device Identifier: 08714729876717
• UDI-Public: 08714729876717
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027425093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: Black Or African American