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); Failure to Advance (2524)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

A2: age at time of event: 18 years or older.

Event Description

It was reported that stent fracture occurred.Vascular access was gained via contralateral approach.The 100% stenosed target lesion was located in the severely calcified and moderately tortuous superficial femoral artery (sfa).A 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use.The lesion was predilated with a peripheral angioplasty balloon.Difficulty occurred crossing the lesion where the chronic total occlusion (cto) was and the stent delivery system would not advance.During deployment, 20-30mm of the stent was deployed and broke off from the rest of the stent system.The 120-130mm of the broken part of the stent became stuck in the sheath.The sheath was then removed and replaced.The remaining 20-30mm portion of the stent was implanted.There were no patient complications, and the patient status was good post procedure.

• 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: 18283275
• MDR Text Key: 329947218
• Report Number: 2124215-2023-69168
• Device Sequence Number: 1
• Product Code: NIU
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 0031205587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE SHEATH: 6X45 TERUMO DESTINATION.; GUIDEWIRE: .035" GWA.