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 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination of the device identified a shaft break was observed 345mm proximal from the distal end of the tip.The device was returned with the stent fully constrained in the device.No issues were noted with the constrained stent.The stent was unable to deploy due to the shaft break.The stent deployed by manually pulling the tip while gripping the outer.No issues were noted with the stent, stent holder or stent cups.A red blood like substance was observed in the device.A visual and microscopic investigation identified no issues with the tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on (b)(6) 2020.It was reported that deployment failure occurred.The target lesion was located in the common carotid artery.A 10.0-24 carotid monorail stent was advanced for treatment.However, it was observed that the stent did not deploy after the t- connector was completely pulled.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, returned device analysis revealed shaft detachment/separation.

• 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: 9865678
• MDR Text Key: 184472696
• Report Number: 2134265-2020-03683
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P050019
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0020178182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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