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); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that the device partially deployed, became unraveled and then detached, requiring an additional device.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a left popliteal and superficial femoral artery stent procedure.Using a contralateral approach, the 100% stenosed, severely tortuous, severely calcified popliteal and distal sfa lesions were pre-dilated with balloon angioplasty.The stenosis after pre-dilation was 60%.Then resistance was noted when crossing the occlusion to the popliteal lesion with this eluvia stent.The stent was deployed using the thumb wheel; however, only 2 cm of the stent was deployed before a popping sound was heard.The pull grip was also used to attempt deployment.Then the device handle was opened to deploy the stent manually without success.An attempt was made to remove the stent and device and upon doing so, the 2cm section of deployed stent became unraveled and detached from the device.Another stent was implanted inside the same area.There were no patient complications.

• 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: 18231456
• MDR Text Key: 329314648
• Report Number: 2124215-2023-64107
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 0030910808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female