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	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent partially deployed and elongated.A 7mm x 150mm, 130cm eluvia drug-eluting vascular stent system was selected for use in a vascular intervention.The 100% stenosed target lesion was located in the moderately calcified and moderately tortuous superficial femoral artery (sfa).About halfway through stent deployment, it became difficult to turn the thumbwheel, and the stent was elongating.An attempt was made to break apart the handle, pin the brown inner catheter, and pull back the middle gray catheter to deploy.It was still very difficult, which cause further stent elongation.The non-boston scientific filter wire was exchanged for a 0.035 wire.At this point, the inner catheter was able to be straightened, and the stent deployed.The elongated portion of the stent was re-lined with another eluvia stent of the same size.The procedure was completed successfully.No patient complications were reported.
Event or Problem Description
It was reported that the stent partially deployed and elongated.A 7mm x 150mm, 130cm eluvia drug-eluting vascular stent system was selected for use in a vascular intervention.The 100% stenosed target lesion was located in the moderately calcified and moderately tortuous superficial femoral artery (sfa).About halfway through stent deployment, it became difficult to turn the thumbwheel, and the stent was elongating.An attempt was made to break apart the handle, pin the brown inner catheter, and pull back the middle gray catheter to deploy.It was still very difficult, which cause further stent elongation.The non-boston scientific filter wire was exchanged for a 0.035 wire.At this point, the inner catheter was able to be straightened, and the stent deployed.The elongated portion of the stent was re-lined with another eluvia stent of the same size.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the handle was open.There was buckling to the outer sheath at the nosecone.There were multiple kinks to the proximal inner near the clip.The pull rack was separated into 3 pieces.The proximal piece was separated 13cm from the knob.The middle piece measured approximately 11.3cm long.Microscopic examination revealed no additional damages.The nosecone was examined under x-ray, and the distal end of the pull rack was inside.Product analysis found damage that would have contributed to the reported event.

• 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: 19930374
• Report Number: 2124215-2024-48905
• Device Sequence Number: 2760119
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 02/15/2026
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0033619972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: Male
• Patient Race: White