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

Model Number 26605

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the right carotid artery.A 8.0-36 carotid wallstent stent was selected for use.However, during unpacking, it was noted that the stent strut was lifted.The procedure was completed with a different device.There were no patient complications.

Event Description

It was reported that stent damage occurred.The target lesion was located in the right carotid artery.A 8.0-36 carotid wallstent stent was selected for use.However, during unpacking, it was noted that the stent strut was lifted.The procedure was completed with a different device.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr.: a carotid wallstent monorail 8.0-36 was received for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was received with the stent in the correct position on the delivery system.The stent was noted to be partially deployed by approximately 5mm.The distal stent wires were also found to be damaged.No other damage or issues were noted with the stent.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12475893
• MDR Text Key: 271520534
• Report Number: 2134265-2021-10996
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0026238697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 85