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

Model Number 24653

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

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

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported that stent elongation with bad apposition occurred requiring additional intervention.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use during a femoral cross-over dilation procedure.During deployment, there was difficulty and the knob jolted.The notch was fully deployed, while the stent was still mostly undeployed.The retrieval of the device resulted in the deployment of the stent and stent elongation with bad apposition.Two additional stents were used to cover the elongated stent.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an eluvia drug-eluting vascular stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed multiple kinks to the sheath.The pull rack is separated at the handle.The proximal end of the separated pull rack did not return for analysis.Microscopic examination revealed no additional damages.

Event Description

It was reported that elongation with bad apposition occurred requiring additional intervention.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use during a femoral cross-over dilation procedure.During deployment, there was difficulty and the knob jolted.The notch was fully deployed, while the stent was still mostly undeployed.The retrieval of the device resulted in the deployment of the stent and stent elongation with bad apposition.Two additional stents were used to cover the elongated stent.

• 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: 18767571
• MDR Text Key: 336113070
• Report Number: 2124215-2024-09259
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0030825445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention