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

Model Number 26605

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2020

Event Type  Injury  

Event Description

It was reported that the stent failed to expand.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified right internal carotid artery.An 8.0-21 carotid wallstent was passed through the lesion for treatment.However, during deployment, the distal end of the stent did not open.The physician tried to open it with a sterling balloon but was unsuccessful.The procedure was completed by implanting another 7x30 carotid wallstent through the previous deployed stent.No patient complications were reported and the patient's 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: 10949253
• MDR Text Key: 219859023
• Report Number: 2134265-2020-16943
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0024240150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50