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

Model Number 24653

Device Problem Premature Activation (1484)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

It was reported that the stent inadvertently deployed outside of the patient.An eluvia drug-eluting vascular stent system was selected for use in the lower extremity arterial stent implantation and balloon dilation catheterization procedure.When the eluvia delivery system was advanced to the target vessel and deployment was attempted, the stent failed to deploy.The delivery system was removed, and the stent inadvertently deployed outside of the patient.The eluvia was exchanged, and the procedure was completed.The patient was reported to be stable following the procedure.

Manufacturer Narrative

Device analysis: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were no longer in the manufactured position.The stent was no longer inside the sheath.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink was attributable to handling after the procedure.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found no damage that could have contributed to the inadvertent deployment.

Event Description

It was reported that the stent inadvertently deployed outside of the patient.An eluvia drug-eluting vascular stent system was selected for use in the lower extremity arterial stent implantation and balloon dilation catheterization procedure.When the eluvia delivery system was advanced to the target vessel and deployment was attempted, the stent failed to deploy.The delivery system was removed, and the stent inadvertently deployed outside of the patient.The eluvia was exchanged, and the procedure was completed.The patient was reported to be stable following the procedure.

• 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: 18240228
• MDR Text Key: 329398328
• Report Number: 2124215-2023-67516
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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: 0030646975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG