MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that obvious crease was found in the stent.The target lesion was located in the femoral artery.An 16x90/9fr wallstent uni was advanced for treatment.However, after balloon dilatation, an apparent crease in the stent was found when it was extracted.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
H6 - device codes: updated from material deformation to material integrity problem.
Event or Problem Description
It was reported that obvious crease was found in the stent.The target lesion was located in the femoral artery.An 16x90/9fr wallstent uni was advanced for treatment.However, after balloon dilatation, an apparent crease in the stent was found when it was extracted.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that 50% stenosed target lesion was located in the severely calcified and mildly tortuous femoral artery and the obvious crease was located in the shaft.
Additional Manufacturer Narrative
H6 - device codes: updated from material deformation to material integrity problem.Device evaluated by mfr: the device was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile inspection found the sheath of the device to be kinked at approximately 30mm proximal of the tip.This type of damage is consistent with excessive force being applied to the delivery system.
Event or Problem Description
It was reported that obvious crease was found in the stent.The target lesion was located in the femoral artery.An 16x90/9fr wallstent uni was advanced for treatment.However, after balloon dilatation, an apparent crease in the stent was found when it was extracted.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that 50% stenosed target lesion was located in the severely calcified and mildly tortuous femoral artery and the obvious crease was located in the shaft.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 18660324
• Report Number: 2124215-2024-06878
• Device Sequence Number: 8002362
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030979812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 02/05/2024; 02/26/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 02/21/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 67 KG