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	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent delivery system was difficult to remove after stent deployment.This 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure.The diffusely diseased, mildly calcified lesion was located in the superficial femoral artery.A contralateral approach was used.After laser atherectomy of the lesion, the eluvia stent was attempted to be deployed over a non-boston scientific guidewire.However, the thumb wheel stopped working after three fourths of the stent was deployed in the lesion.The pull grip was used, and the remainder of the stent was deployed.Then the physician removed one fourth of the catheter into the guide sheath when it became stuck.The physician cut the deployment handle from the catheter and the catheter and guidewire were successfully removed.There were no patient complications.There is no product available for return.
Event or Problem Description
It was reported that the stent delivery system was difficult to remove after stent deployment.This 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure.The diffusely diseased, mildly calcified lesion was located in the superficial femoral artery.A contralateral approach was used.After laser atherectomy of the lesion, the eluvia stent was attempted to be deployed over a non-boston scientific guidewire.However, the thumb wheel stopped working after three fourths of the stent was deployed in the lesion.The pull grip was used, and the remainder of the stent was deployed.Then the physician removed one fourth of the catheter into the guide sheath when it became stuck.The physician cut the deployment handle from the catheter and the catheter and guidewire were successfully removed.There were no patient complications.There is no product available for return.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia self-expanding stent system was returned with an unknown 0.014-inch guidewire stuck in the device.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the outer sheath was separated 3mm from the nosecone.The pull rack was separated at the handle and the proximal section of the pull was missing.There were multiple kinks along the outer sheath.The inner liner was kinked 13cm from the tip.Microscopic examination revealed no additional damages.The stent was deployed and was not returned for analysis.X ray examination of the handle showed the proximal inner was prolapsed.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 and difficulty to remove.

• 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: 17968085
• Report Number: 2124215-2023-54886
• Device Sequence Number: 7754810
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/20/2023

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: 01/11/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028752598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown