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

Model Number 24653

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported that the stent inadvertently deployed.This 6x120, 75 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty of the superficial femoral artery.During preparation, the package was opened, and the stent was observed to be partially deployed.The stent was not used, and the procedure was completed using another eluvia device.There were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia self-expanding stent system was inspected for damage.Visual examination of the outer sheath, tip, inner sheath, and the remainder of the device revealed a kink to the outer sheath at the nosecone, and 12.5cm from the distal end of the middle sheath.The stent was partially deployed 7mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that would have contributed to the inadvertent deployment.

Event Description

It was reported that the stent inadvertently deployed.This 6x120, 75 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty of the superficial femoral artery.During preparation, the package was opened, and the stent was observed to be partially deployed.The stent was not used, and the procedure was completed using another eluvia device.There were no patient 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: 18587403
• MDR Text Key: 333933034
• Report Number: 2124215-2024-00962
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: SN
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0031325118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1