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

Model Number 24657

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 07/27/2023

Event Type  malfunction  

Event Description

It was reported that the stent premature deployed.This 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a lower extremity angiogram for peripheral artery disease.It was noted that a contralateral approach was used for the procedure.The stent prematurely deployed in the sheath.The sheath was removed, and re-access of the artery was performed.The procedure was completed using a new stent.The patient fully recovered.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, it was found that the delivery sheath was not returned for analysis.Visual examination revealed that the stent was damaged and stuck inside an unknown sheath.The stent appeared to have been separated and the distal section was missing.Microscopic examination revealed no additional damages.X ray examination of the sheath revealed that the proximal section of the stent was completely inside the introducer sheath.The struts could be visualized damaged inside the sheath.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed that the stent was deployed inside a sheath.

Event Description

It was reported that the stent premature deployed.This 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a lower extremity angiogram for peripheral artery disease.It was noted that a contralateral approach was used for the procedure.The stent prematurely deployed in the sheath.The sheath was removed, and re-access of the artery was performed.The procedure was completed using a new stent.The patient fully recovered.

• 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: 17542263
• MDR Text Key: 321087385
• Report Number: 2124215-2023-43360
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030898823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1