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

Model Number 26605

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned with the stent fully crimped onto the delivery system.A visual and microscopic examination identified a middle outer break 165mm proximal from the distal end of the tip (1200mm from distal end of strain relief).This middle outer shaft break prevented deployment of the stent using the handle.No issues were noted with the catheter that could have contributed to the damage identified.The damage identified is consistent with excessive force being applied to the delivery system.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.The stent was returned fully mounted onto the delivery system.A visual and microscopic examination of the crimped stent identified no issues.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 26jun2019.It was reported that advancing difficulties were encountered.The 70% stenosed target lesion was located in the carotid artery.A 8.0-29 carotid wallstent was selected for use.However, it was noted that the stent failed to advance after multiple attempts.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft was detached/separated.

• 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: 8772624
• MDR Text Key: 150440697
• Report Number: 2134265-2019-07918
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P900056
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0023074651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• 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
• Patient Age: 52 YR
• Patient Weight: 65