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

Model Number 24657

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

It was reported that partial deployment of stent and stent elongation occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for a sfa atherectomy, angioplasty and stenting procedure.The stent was placed post atherectomy over a.014 thruway guidewire.The stent was only partially deployed.The physician had to pull the entire delivery system back to completely deploy the stent, and it was significantly elongated.Upon removal of the delivery catheter, it was stuck on the guidewire.Both delivery catheter and guidewire had to be removed together.There were no patient complications, and the case was completed satisfactorily.

• 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: 18103245
• MDR Text Key: 327887446
• Report Number: 2124215-2023-62478
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 0030893339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male