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

Model Number	24657
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent partial deployment, damage and fracture occurred requiring additional intervention.Vascular access was obtained via antegrade approach.The totally occluded target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery (sfa).A cut down was performed to visualize the femoral artery and eventually cannulate the vessel for the endo portion of the intervention.Angiograms were obtained showing diffuse disease throughout the entire sfa with a short chronic totally occluded (cto) portion.The lesion was crossed and predilated with a ranger balloon.The post balloon image showed extravasation.A 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use.The first approximately 40-50mm of the stent deployed with no issues, using normal force.A point was reached where the deployment system failed, even before the pull grip portion.The physician pulled everything in an attempt to remove it all which then stretched the entire stent out 10-12cm and the stent fractured.The physician attempted to put a wire and catheter back down to place a second stent inside the damaged one, but nothing would cross the fractured stent.The physician decided to surgically cut down to take the stent out, but it came out in pieces and some of the stent remained in the vessel.Access was gained again using a wire and a 7x150 eluvia and a 7x100 eluvia stent were placed.The lesion was post dilated with a 6x100 mustang balloon.Post imaging looked great.The patient is expected to fully recover.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: 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: 20232882
• Report Number: 2124215-2024-57166
• Device Sequence Number: 8754824
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2026
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0033528903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: .014X300 THRUWAY
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown