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

Model Number 26605

Device Problem Material Deformation (2976)

Patient Problem Vasoconstriction (2126)

Event Date 11/16/2021

Event Type  Injury  

Event Description

It was reported that stent damage occurred and the patient experienced vasospasm.The 75% stenosed target lesion was located in the mildly tortuous and moderately calcified internal carotid artery.A 10.0-31 carotid wallstent was advanced to treat the lesion.After the device was deployed inside the patient, vessel spasm was noted which was thought may be caused by stent stimulation.The device was removed and after withdrawal of the device, the stent strut was found to be lifted.The procedure was completed with a different device.No further patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the carotid wallstent monorail device was received for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was received with the stent in the correct position on the delivery system.For investigation purposes the investigator partially deployed the stent to facilitate exposure and examination of the distal stent wires.The distal stent wires were found to be damaged.The stent damage could potentially have occurred due to the stent encountering resistance during deployment.No other damage or issues were noted with the stent.

Event Description

It was reported that stent damage occurred and the patient experienced vasospasm.The 75% stenosed target lesion was located in the mildly tortuous and moderately calcified internal carotid artery.A 10.0-31 carotid wallstent was advanced to treat the lesion.After the device was deployed inside the patient, vessel spasm was noted which was thought may be caused by stent stimulation.The device was removed and after withdrawal of the device, the stent strut was found to be lifted.The procedure was completed with a different device.No further patient complications were reported and the patient status was stable.

• 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: 12910633
• MDR Text Key: 281581902
• Report Number: 2134265-2021-14806
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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: 0027362993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2021
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG