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 Failure (3270); Poor Visibility (4072)

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

Event Date 05/20/2023

Event Type  Injury  

Event Description

It was reported that the stent failed to fully expand, and the stent was difficult to visualize under fluoroscopy.This eluvia drug-eluting vascular stent system 6x100, 130 cm was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery.During the procedure, the stent did not fully expand, and the stent strut was difficult to visualize under fluoroscopy.The procedure was completed with a different stent.No patient complications were reported.

Event Description

It was reported that the stent failed to fully expand, and the stent was difficult to visualize under fluoroscopy.This eluvia drug-eluting vascular stent system 6x100, 130 cm was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery.During the procedure, the stent did not fully expand, and the stent strut was difficult to visualize under fluoroscopy.The procedure was completed with a different stent.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia drug-eluting vascular stent system 6x100, 130 cm was inspected for damage.Visual examination revealed multiple kinks along the sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position and the stent was still inside the sheath.X-ray evaluation revealed that the stent could be visualized.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found no damage that could have contributed to the failure to expand or the not visible under fluoroscopy.

• 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: 17117190
• MDR Text Key: 317047555
• Report Number: 2124215-2023-26333
• 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,Followup
• Report Date: 08/07/2023

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 Expiration Date: 06/30/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027661525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male