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

Model Number 24657

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

Device eval by manufacturer: this eluvia drug-eluting vascular stent system (with 0.014 thruway inside) was returned and analyzed.Visual examination revealed that the handle was open and the side with the batch number printed on it was missing.The proximal end of the inner liner, proximal inner, and clip were also missing.The stent was partially deployed and was separated 1 cm from the distal end of the middle sheath.The stent measures approximately 11.7 cm long.Inspection revealed multiple kinks along the middle and outer sheath.Microscopic examination revealed no further damages.The tip could not be moved, so an x-ray was performed that revealed the inner liner was separated inside the nosecone.Review of the instructions for use (ifu) indicates that an 0.035 stiff guidewire of appropriate length should be used for deployment.It appears that use of an undersized guidewire likely led to insufficient support causing the deployment and subsequent issues observed in the field.

Event Description

It was reported that the stent stretched and migrated with difficult deployment.This eluvia drug-eluting vascular stent 7 mm x 150 mm x 130 cm was selected for use in the superficial femoral artery (sfa) as treatment for peripheral artery disease.The lesion had moderate calcification and mild tortuosity.Pre-dilation was performed with 4 mm x 120 mm coyote balloon, and the eluvia was advanced over.014 thruway guidewire.About 50 mm into stent deployment the delivery handle and thumb wheel failed.The physician attempted to deploy by pulling on the delivery handle and disassembling the stent handle.After several attempts to deliver, the stent became elongated and migrated from the distal sfa into the proximal sfa and common femoral artery.The stent eventually fractured near the middle of the stent, and the remaining portion was withdrawn from the patient.A balloon was inflated to break the stent struts, and the physician continued the procedure by deploying more stents successfully.The other portion of the fractured stent was covered by another eluvia in the profunda artery.The procedure was considered successful, and the patient was 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: 18571388
• MDR Text Key: 333608380
• Report Number: 2124215-2023-76200
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0031836062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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
• Treatment: 0.014 THRUWAY.; 4 MM X 120 MM COYOTE.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White