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

Model Number 26606

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Coma (2417)

Event Date 02/04/2021

Event Type  Death  

Event Description

It was reported that patient death occurred.The 70% stenosed target lesion was located in the moderately tortuous and non-calcified common carotid artery.The patient was administered general anesthesia.A 3x40mm and 4.5x40mm sterling balloon catheter, 10x24mm carotid wallstent and 3.5-5.5 190cm filterwire were selected for a carotid angioplasty and stenting (cas) procedure.The devices were used in accordance with the instructions for use (ifu).The procedure was completed and there were no patient adverse events.The patient was unable to regain consciousness from the procedure.Magnetic resonance imaging (mri) was performed and it was observed that the left hemisphere became white.The patient remained unconscious.The following day the patient died.The physician commented that the liquid substance from ulceration and the plaque from the lesion may have flown to the periphery and caused cerebral infarction.

• 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: 11473861
• MDR Text Key: 239429935
• Report Number: 2134265-2021-02382
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0026004060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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
• Treatment: BALLOON CATHETER: STERLING; GUIDE CATHETER: FUBUKI8F; GUIDEWIRE: FWEZ
• Patient Outcome(s): Death
• Patient Age: 83 YR