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

Model Number 26605

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: received carotid device with the stent.The device was received with the stent fully constrained in the correct position on the delivery system.Although the stent had not been deployed it was found to be kinked at approximately 5mm proximal of the distal markerband.This type of damage is consistent with excessive force being applied to the device.A visual and tactile inspection of the device found the shaft to be kinked at more than one location.One of the kinks was found to be at the same location as the stent kink.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 18nov2020.It was reported that sheath kink occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common carotid artery.A 6.0-22 carotid monorail wallstent was advanced but the sheath surrounding the stent was bent.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed stent damage.

• Brand Name: CAROTID WALLSTENT
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10949303
• MDR Text Key: 219909339
• Report Number: 2134265-2020-16929
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0020602365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR