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 expand fully, and an additional device was required to adequately treat the lesion.An eluvia drug-eluting vascular stent system was selected for use to treat an arteriovenous fistula.The target lesion was located in the superficial femoral artery and was reported to have severe calcification and tortuosity and was 100% stenosed.The lesion was predilated, and the eluvia delivery system was advanced over a non-boston scientific guidewire.When the eluvia delivery system passed the common iliac bifurcation, it was difficult to advance the device.The stent was deployed without issue, but once deployed, the stent failed to fully expand.The stent was post-dilated, but the physician relayed that the radial force was insufficient to treat the lesion.An additional eluvia was deployed to complete the procedure.The patient condition was reported to be good and there were no complications.

• 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: 17646112
• MDR Text Key: 322220482
• Report Number: 2124215-2023-46612
• 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: 08/07/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027928216
• 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: 08/07/2021
• 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