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

Model Number 26605

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination found that the stent of the device had been deployed.It is not known when the stent was deployed.The deployed stent was damaged.The stent cups and holder could not be analysed due to a severe kink to the stainless-steel shaft.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified a severe kink to the stainless-steel shaft located approximately 20mm distal of the point of no return marker.As the device was fully constrained, the kink must have occurred post deployment of the stent.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 14-oct-2020.It was reported that stent failure to deploy occurred.The 90% stenosed target lesion was located in the internal carotid artery.A 8.0-21mm carotid monorail wallstent was advanced to treat the lesion.However, the stent could not be deployed during procedure.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.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: 10749625
• MDR Text Key: 213496984
• Report Number: 2134265-2020-14846
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0025122289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2020
• 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: 63 YR
• Patient Weight: 65