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

Model Number 26605

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned with the stent fully crimped onto the delivery system.A complete break in the outer sheath and inner shaft of the catheter was found.The break in outer sheath was located approximately 35mm distal to the t connector and the break in the inner shaft was located approximately 67mm distal to the t connector.The break in the outer sheath was approximately 120mm in length and the break in the inner shaft approximately 90mm in length.Kinking damage was also noted at the shaft break locations.This outer sheath and inner shaft break prevented stent deployment, as the inner shaft could not be pushed forward to allow for deployment.No issues were noted with the catheter that could have contributed to the damage identified.The catheter damage identified is consistent with excessive force being applied to the delivery system.The stent was returned fully crimped onto the delivery system.A visual and microscopic examination of the crimped stent identified no damage or any issues.Due to the condition of the returned device the investigator could not deploy the stent.No issues were noted with the stent that could have contributed to the complaint incident.A visual and microscopic examination was performed on the tip and markerbands of the device.No damage or any issues were noted 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 30, may 2019.It was reported that the stent failed to deploy.A 10.0-31 carotid wallstent was selected for a carotid stenting procedure.During the procedure, resistance was noted while attempting to release the stent.No portion of the stent was deployed out of the sheath.The device was removed and the procedure was completed with another of the same device successfully.No patient complications were reported.However, device analysis revealed a break in the outer and inner shaft.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8716192
• MDR Text Key: 148545575
• Report Number: 2134265-2019-07157
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2019

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: 04/15/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0022791878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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