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

Model Number 24653

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

It was reported that it was difficult to remove the stent delivery system from the patient.An eluvia eu, 6x120, 130 cm was selected for use in the superficial femoral artery (sfa) for the percutaneous angioplasty procedure.The target lesion was reported to be 90 percent stenosed, with moderate tortuosity and calcification.The target lesion was predilated prior to stent placement.After successfully deploying the stent in the sfa, the delivery system was attempted to be withdrawn, but it interfered with the 0.014 in micro guidewire, making removal difficult.The micro guidewire was removed first in order to proceed with the procedure.The procedure was completed and there were no adverse consequences reported to the patient.

Manufacturer Narrative

Device media analysis: returned product consisted of an eluvia self-expanding stent system from batch 29133956 with an unknown 0.014 in.Guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the sheath was kinked at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.In addition to the device analysis becoming available, additional information was provided regarding the device lot number and the origin of the micro guidewire.Sections b5 and d4 have been updated.

Event Description

It was reported that it was difficult to remove the stent delivery system from the patient.An eluvia eu, 6x120, 130 cm was selected for use in the superficial femoral artery (sfa) for the percutaneous angioplasty procedure.The target lesion was reported to be 90 percent stenosed, with moderate tortuosity and calcification.The target lesion was predilated prior to stent placement.After successfully deploying the stent in the sfa, the delivery system was attempted to be withdrawn, but it interfered with the 0.014 in non-bsc micro guidewire, making removal difficult.The micro guidewire was removed first in order to proceed with the procedure.The procedure was completed and there were no adverse consequences reported to the patient.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway MA ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16341866
• MDR Text Key: 309276023
• Report Number: 2124215-2023-05559
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0029133956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1