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

Model Number 26605

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 01/29/2024

Event Type  Injury  

Event Description

It was reported that vessel dissection occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified intracranial vertebral segment (v2).An 8.0-29 carotid wallstent was advanced for treatment but failed to cross the lesion.Per the physician's opinion, the stent contributed to dissection.The procedure was completed with a different device.The patient condition was stable following the procedure.

Manufacturer Narrative

A carotid device was received for analysis.A visual and tactile examination identified no issues with the shaft of the device.The device was returned with the stent fully mounted in the correct location on the device.

Event Description

It was reported that vessel dissection occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified intracranial vertebral segment (v2).An 8.0-29 carotid wallstent was advanced for treatment but failed to cross the lesion.Per the physician's opinion, the stent contributed to dissection.The procedure was completed with a different device.The patient condition was stable following the procedure.It was further reported that a type-a or non-flow limiting dissection was noted.Continuous flushing was applied, and anticoagulant was given to the patient during and after the procedure.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18705524
• MDR Text Key: 335376287
• Report Number: 2124215-2024-08003
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0032371575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• 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 Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 48 KG