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 Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of an eluvia self-expanding stent system with an unknown introducer sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open.The inner liner is stuck inside the introducer sheath.There are multiple kinks along the outer sheath and middle sheath.The inner liner is separated at the clip.The middle sheath is separated at the retainer.Microscopic examination revealed no additional damages.The introducer sheath was x-rayed, and the proximal end of the separated stent is stuck inside.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that would have contributed to the deployment issue.
Event or Problem Description
It was reported that the stent partially deployed, and stent fracture occurred.The pre-dilated target lesion was located in the severely calcified, 100% stenosed distal superficial femoral artery (sfa).A 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for the procedure to treat peripheral arterial disease (pad).After a contralateral approach and deployment of first 1/3-1/2 of the stent, the wheel was no longer functional, and neither was the blue pull.The device was opened to attempt to manually deploy, but the stent elongated and fractured, partially deploying in the sheath.A portion of the stent was forcefully removed, and non-boston scientific stents were placed to cover the sfa and over stent the fractured portion of the eluvia stent.The patient is expected to fully recover.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• 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: 20316817
• Report Number: 2124215-2024-59740
• Device Sequence Number: 18088249
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: 02/07/2026
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0033519540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown