BEUDAMED
    FDA Adverse Event Death Summary report: N

    IC 71, 132 CM, US

    MDR report key: 18571314 · Received January 24, 2024

    Report

    Report Number
    3007628272-2024-00007
    Event Type
    Death
    Date Received
    January 24, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 24, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31101932 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. ISCHEMIC STROKE, OR LACK OF BLOOD FLOW TO THE BRAIN, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH BOTH THE EMBOGUARD AND THE IC 71, 132 CM, US CEREGLIDE INTERMEDIATE CATHETER AND IS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH FOR BOTH DEVICES. THERE WERE NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICES, AS THE DEVICES PERFORMED AS INTENDED. IT IS CURRENTLY UNCLEAR WHAT CAUSED THE LACK OF BLOOD FLOW, HOWEVER, BASED ON THE ANGIOGRAM BEING PERFORMED AFTER THE THROMBUS RETRIEVAL, THE POSSIBILITY OF A DISTAL EMBOLIZATION CAUSED BY THE DEVICES CANNOT BE RULED OUT ENTIRELY. ADDITIONALLY, THE EVENT WAS SAID TO CAUSE ¿IRREVERSIBLE COMA¿ TO THE PATIENT. BASED ON THE LIMITED INFORMATION AVAILABLE, THIS EVENT DOES MEET US FDA REPORTING CRITERIA. PER THE ADDITIONAL INFORMATION RECEIVED ON 10-JAN-2024, IT WAS MADE KNOWN THAT THE PATIENT HAS EXPIRED. ADDITIONALLY, THE TREATING PHYSICIAN ATTRIBUTED THE EVENT (LACK OF BLOOD FLOW TO THE BRAIN) TO VESSEL TRAUMA CAUSED BY THE USED CERENOVUS DEVICES; ¿PROLAPSE OF EMBOGUARD CONTRIBUTED TO FORWARD TENSION APPLIED TO CEREGLIDE.¿ BASED ON THIS INFORMATION, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿DEATH,¿ WITH AN AWARENESS DATE OF 10-JAN-2024. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3007628272-2024-00007 AND 3011370111-2024-00007.

    Description of Event or Problem · 0

    IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EMBOGUARD 87, 85 CM (BG8785U/ 0000203033) AND AN IC 71, 132 CM, US CEREGLIDE INTERMEDIATE CATHETER (NIC71132U/ 31101932) WAS USED FOR A THROMBECTOMY PROCEDURE. PER THE EVENT DESCRIPTION, ¿CEREGLIDE TRACKED TO THE CLOT AND REMOVED WITH ASPIRATION. PHYSICIAN PERFORMED ANGIOGRAM AND NOTED A LACK OF BLOOD FLOW TO THE BRAIN. PROCEDURE WAS DISCONTINUED.¿ THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS ¿IRREVERSIBLE COMA.¿ THE EVENT REQUIRED THE MEDICAL INTERVENTION OF A ¿[COMPUTED TOMOGRAPHY] CT.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 10-JAN-2024. SUMMARY: PER THE INFORMATION RECEIVED, THE PATIENT¿S BASELINE/PRE-PROCEDURE NEUROLOGICAL STATUS WAS ¿LEFT SIDED SENSORY AND UPPER EXTREMITY MOTOR DEFICITS.¿ THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN; ¿UNKNOWN (TRANSFER FROM OUTSIDE HOSPITAL).¿ THE TREATING PHYSICIAN'S OPINION ON CONTRIBUTING FACTORS FOR THE EVENT OF LACK OF BLOOD FLOW TO BRAIN WAS ¿PROLAPSE OF EMBOGUARD CONTRIBUTED TO FORWARD TENSION APPLIED TO CEREGLIDE.¿ IT WAS FURTHER COMMENTED THAT THE EVENT WAS ASSOCIATED WITH VESSEL TRAUMA FROM THE DEVICES. ¿NO DAMAGE OF PRODUCTS WAS NOTED.¿ ANOTHER CONCOMITANT DEVICE USED DURING THE PROCEDURE WAS THE ARISTOTLE 24 WIRE (SCIENTIA VASCULAR); ¿CEREGLIDE TRACKED OVER ARISTOTLE 24 WIRE. CEREGLIDE TRACKED THROUGH EMBOGUARD.¿ THE LOCATION OF THE TARGET LESION WAS THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE RESULTS OF THE CT (COMPUTED TOMOGRAPHY) WERE NOT MADE AVAILABLE; ¿CT IS RECORDED AT THE HOSPITAL.¿ IT WAS ALSO DISCLOSED THAT THE CURRENT STATUS OF THE PATIENT IS ¿EXPIRED.¿ THE DATE OF DEATH WAS (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317951 IC 71, 132 CM, US CATHETER, ASPIRATION CATHETER NRY CERENOVUS, INC. 31101932 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Death ARISTOTLE 24 WIRE (SCIENTIA VASCULAR)| EMBOGUARD 87, 85 CM