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

Model Number 24653

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 10/05/2023

Event Type  Injury  

Event Description

It was reported that premature deployment occurred.This 7x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 99% stenosed, moderately calcified, moderately tortuous lesion was located in the superficial femoral artery.During the procedure, the lesion was pre-dilated; however, deployment failure occurred, and the stent was stretched during the attempted stent placement.The procedure was completed with another of the same device and there was no patient injury.

Event Description

It was reported that premature deployment occurred.This 7x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 99% stenosed, moderately calcified, moderately tortuous lesion was located in the superficial femoral artery.During the procedure, the lesion was pre-dilated; however, deployment failure occurred, and the stent was stretched during the attempted stent placement.The procedure was completed with another of the same device and there was no patient injury.It was further reported that the previously reported 7x40, 130 cm eluvia drug-eluting vascular stent system was implanted with 20mm of the stent elongated.An additional eluvia stent was implanted.Post dilation was performed with a balloon.

• 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: 17990334
• MDR Text Key: 326368065
• Report Number: 2124215-2023-58822
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0031283726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ELUVIA STENT
• Patient Outcome(s): Required Intervention