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

Model Number 24653

Device Problems Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2023

Event Type  Injury  

Event Description

It was reported that the stent failed to fully expand, and the radial force was insufficient to treat the target lesion.An additional stent was required to adequately treat the target lesion.An eluvia drug-eluting vascular stent system 6x120, 130cm was selected for use in the superficial femoral artery (sfa).The target lesion was 100% stenosed with severe calcification and tortuosity.The target lesion was approached contralaterally using a non-boston scientific guidewire and an unknown guide sheath.When the eluvia delivery system passed through the common iliac bifurcation, there was difficulty advancing.Once at the target lesion, the eluvia stent was deployed without difficulty.Once the stent was deployed, the physician determined that the stent failed to expand fully, and that the radial force was insufficient to treat the target lesion.An additional eluvia stent was required to adequately treat the target lesion.The procedure was completed, and there were no reported adverse consequences for the patient.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: 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: 17647724
• MDR Text Key: 322241418
• Report Number: 2124215-2023-46600
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0029046063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female