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

Model Number	26665
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent profile problem occurred.The 7mm target lesion was located in carotid artery.A 10x37,5.9f,135cm carotid wallstent stent was implanted.However, the device was elongated above the length of 70mm.The procedure was completed.No patient complications were reported and the patient condition was good.
Additional Manufacturer Narrative
B5- describe event or problem: updated.
Event or Problem Description
It was reported that stent profile problem occurred.The 7mm target lesion was located in carotid artery.A 10x37,5.9f,135cm carotid wallstent stent was implanted.However, the device was elongated above the length of 70mm.The procedure was completed.No patient complications were reported and the patient condition was good.It was further reported that the target lesion was 70% stenosed, 40mm in length, moderately tortuous and mildly calcified.The diameter of the target lesion had a size discrepancy (4mm-7mm).The stent was deployed and elongated beyond its indicated size.The physician decided to leave the stent inside the patient.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15329009
• Report Number: 2124215-2022-31337
• Device Sequence Number: 17763454
• Product Code: NIM
• UDI-Device Identifier: 08714729781141
• UDI-Public: 08714729781141
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 09/06/2024
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0026927789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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 Sex: Male