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

Model Number	26665
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received with the stent in the correct place on the delivery system.The stent could not be fully deployed due to a severe kink and complete break in the outer shaft of the device.A visual and tactile inspection identified a complete break of the outer shaft located approximately at the guidewire port.A severe kink on the inner shaft was also identified at the same location.This type of damage is consistent with excessive force being applied to the device.A visual and microscopic examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 23jul2020.It was reported that stent deployment failure occurred.A 10x31,5.9f,135cm carotid wallstent was advanced for treatment but failed to deploy.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed shaft detached/separated.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10356206
• Report Number: 2134265-2020-10334
• Device Sequence Number: 3462615
• Product Code: NIM
• UDI-Device Identifier: 08714729781127
• UDI-Public: 08714729781127
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 03/05/2022
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0022600937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1