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

Model Number 26605

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the left carotid artery.A 10.0-31 carotid wallstent was advanced after pre-dilation was completed and a fliterwire placed.However, after two attempts, the stent was not able to cross the lesion and the tip of the stent was lifted.The procedure was not completed.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned with the stent fully mounted onto the delivery system.A visual and microscopic examination was performed on the returned device.A visual and tactile examination identified a complete break in the outer sheath, beginning at the monorail exit port and extending proximally along the catheter for approximately 104mm.Multiple kinks were also noted, along with one severe kink approximately 116mm distal to the strain relief on the catheter of the device.The damage identified is consistent with excessive force being applied to the delivery system.No issues were noted with the catheter that could have contributed to the damage identified.The stent was returned fully mounted onto the delivery system.Due to the condition of the returned device the investigator could not deploy the stent as per dfu instructions.The investigator had to manually deploy the stent by pulling the tip distally.No resistance or issues were encountered during manual deployment.A visual and microscopic examination of the deployed stent identified no damage or any issues which could have contributed to the complaint incident.A visual and microscopic examination was performed on the stent holder, stent cups, 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

It was reported that stent damage occurred.The target lesion was located in the left carotid artery.A 10.0-31 carotid wallstent was advanced after pre-dilation was completed and a fliterwire placed.However, after two attempts, the stent was not able to cross the lesion and the tip of the stent was lifted.The procedure was not completed.There were no patient complications reported and the patient was stable.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8505937
• MDR Text Key: 141733432
• Report Number: 2134265-2019-03774
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0022659779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 63