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

Model Number 24653

Device Problem Activation Failure (3270)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported that the stent failed to fully expand.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure.The target lesion was severely calcified and located in severely tortuous anatomy.The eluvia was deployed, but the radial force was not enough to treat the lesion.The stent was not fully expanded.The procedure was completed with this device.No patient complications were reported.

Event Description

It was reported that the stent failed to fully expand.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure.The target lesion was severely calcified and located in severely tortuous anatomy.The eluvia was deployed, but the radial force was not enough to treat the lesion.The stent was not fully expanded.The procedure was completed with this device.No patient complications were reported.It was further reported that a contralateral approach was used to access the 100% stenosed target lesion in the superficial femoral artery with a vessel diameter of 6mm.The lesion was pre and post dilated.

Event Description

It was reported that the stent failed to fully expand.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure.The target lesion was severely calcified and located in severely tortuous anatomy.The eluvia was deployed, but the radial force was not enough to treat the lesion.The stent was not fully expanded.The procedure was completed with this device.No patient complications were reported.It was further reported that a contralateral approach was used to access the 100% stenosed target lesion in the superficial femoral artery with a vessel diameter of 6mm.The lesion was pre and post dilated.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15956335
• MDR Text Key: 307774191
• Report Number: 2124215-2022-50397
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0026863325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male