MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number	26665
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The stenosed target lesion was located in the carotid artery.An 8x29, 5f, 135cm carotid wallstent was selected for use.However, upon inspection prior to insertion, it was noted that the stent looked damaged or bent.The device was replaced with a new 8x29 mr carotid wallstent, and the procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the carotid device was returned for analysis.A visual and tactile examination identified a sheath kink approximately 310mm proximal from the distal tip.The device was returned with the stent fully mounted in the correct location on the device.The investigator deployed the stent without any issue.No damage or issues were noted with the deployed stent.Based on analysis of the returned product, the reported allegations could not be confirmed.
Event or Problem Description
It was reported that stent damage occurred.The stenosed target lesion was located in the carotid artery.An 8x29, 5f, 135cm carotid wallstent was selected for use.However, upon inspection prior to insertion, it was noted that the stent looked damaged or bent.The device was replaced with a new 8x29 mr carotid wallstent, and the procedure was completed successfully.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• 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: 19325968
• Report Number: 2124215-2024-29773
• Device Sequence Number: 6680519
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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 Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0032972414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2023
• 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: 74 YR
• Patient Sex: Female