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

Model Number 26606

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the stent was returned partially deployed from the delivery system.The distal stent wires were noted to be damaged.This type of damage is consistent with the stent encountering resistance during deployment.The stent was successfully deployed with some resistance due to solidified media within the delivery system.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 15-dec-2020.It was reported that stent failure to deploy occurred.The 80% stenosed target lesion was located in the severely tortuous common carotid artery.A 10.0-31 carotid wallstent monorail stent was advanced but failed to deploy.When the device was removed and checked outside the patient's body, it was noticed that there was a considerable resistance during deployment.The procedure was completed with a different device.There were no patient complications reported.However, returned device analysis revealed that the distal stent struts were damaged.

• 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: 11038236
• MDR Text Key: 222394250
• Report Number: 2134265-2020-18091
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0025576148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• 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: 61 YR