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

Model Number 24653

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

It was reported the wire became stuck and was difficult to remove.A 6mm x 40mm x 130cm eluvia stent was selected for use in a percutaneous transluminal angioplasty procedure, within the left superficial femoral artery (sfa).The target lesion was 100% stenosed, with moderate tortuosity and severe calcification.Treatment was performed by contralateral approach.After treating the distal with the non-bsc 0.014 guidewire system, it was replaced with non-bsc 0.035 guidewire system.When trying to remove the delivery system after placing the stent, the guidewire and stent became stuck and could not be removed.The entire system was eventually removed as one unit.The physician decided to perform an intravascular ultrasound to observe the lesion in order to determine whether additional treatment was needed, after post-dilatation.Another guidewire was inserted into the patient to continue and the procedure was successfully completed.Stent placement was good and there was no adverse effect 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 ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11555793
• MDR Text Key: 242006323
• Report Number: 2134265-2021-03731
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023626212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• 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