BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19259648 · Received May 7, 2024

    Report

    Report Number
    3007628272-2024-00028
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 18, 2024
    Report Date
    May 7, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    QJP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. SECTION E1. INITIAL REPORTER PHONE: (B)(6). THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31214452 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. INTERFERENCE OR FRICTION BETWEEN DEVICES IS A KNOWN OCCURRENCE. REMOVAL AND EXCHANGE OF DEVICES IS COMMON ROUTINE PRACTICE IN ENDOVASCULAR PROCEDURES. IF RESISTANCE IS ENCOUNTERED, THE SYSTEM BEING INSERTED SHOULD BE WITHDRAWN AS A UNIT TO PREVENT INJURY. THIS IS A COMMON PRACTICE DURING PROCEDURES AND IS RECOMMENDED IN PRODUCT IFU¿S. SINCE THE VAST MAJORITY OF DIAGNOSTIC AND INTERVENTIONAL ANGIOGRAPHIC PROCEDURES UTILIZE MULTIPLE DEVICE EXCHANGES, AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. HOWEVER, IN THIS CASE, THE RIGHT VERTEBRAL ARTERY WAS FOUND TO BE DISSECTED AFTER RECANALIZATION WAS ACHIEVED. THE TREATING PHYSICIAN WAS UNCERTAIN IF THE DISSECTION WAS CAUSED BY THE ¿PULL/TRACTION¿ OF THE TREVO MICROCATHETER (STRYKER) OR THE CEREGLIDE71 INTERMEDIATE CATHETER; THEREFORE, THE CORRELATING RELATIONSHIP BETWEEN EVENT TO THE CEREGLIDE71 CATHETER AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT ENTIRELY. ADDITIONALLY, IT WAS REPORTED THE ¿PATIENT'S POSTOPERATIVE CONDITION IS BAD,¿ AND THE EVENT REQUIRED PROLONGED HOSPITALIZATION. BASED ON THIS INFORMATION, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A 132CM CEREGLIDE 71 CATHETER (NIC71132C/LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY OF LEFT VERTEBRAL ARTERY OCCLUSION. DURING THE PROCEDURE, THE USER REPORTED RESISTANCE/FRICTION OF THE CEREGLIDE71 INNER LUMEN WITH NO LOSS OF CEREBRAL TARGET POSITION. AFTER RECANALIZATION WAS ACHIEVED, THE RIGHT VERTEBRAL ARTERY WAS FOUND TO BE DISSECTED. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF LEFT VERTEBRAL ARTERY OCCLUSION. THE DEVICES WERE USED ACCORDING TO IFU. CEREGLIDE 71 WAS ATTEMPTED TO BE ACCESSED FROM THE RT-VA (RIGHT VERTEBRAL ARTERY), BUT ENCOUNTERED RESISTANCE AT THE MIDDLE RT-VA. FROM THE RESISTANCE LOCATION, A MICROCATHETER WAS ADVANCED TO THE POSTERIOR CEREBRAL ARTERY. THEN A TREVO WAS DELIVERED AND DEPLOYED; HOWEVER, RECANALIZATION WAS NOT OBTAINED. FOR THE SECOND PASS, TREVO WAS DELIVERED AND DEPLOYED. THEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE CEREGLIDE 71 FORWARD USING THE DEPLOYED TREVO AS AN ANCHOR, BUT THERE WAS RESISTANCE. THE TREVO WAS PULLED. SUBSEQUENTLY, ANGIOGRAPHY WAS PERFORMED AND SHOWED RECANALIZATION WAS ACHIEVED, BUT THE RT-VA WAS DISSECTED. POST-PROCEDURE CHANGES IN THE PATIENT: PATIENT'S POSTOPERATIVE CONDITION IS BAD. THE PATIENT IS STILL IN THE HOSPITAL. THE PHYSICIAN¿S ASSESSMENT OF THE HEALTH HAZARD: SERIOUS. PHYSICIAN¿S COMMENT ON THE RELATIONSHIP BETWEEN THIS EVENT AND THE PRODUCT: THE DISSECTION COULD BE CAUSED BY TREVO OR IT COULD BE CAUSED BY CEREGLIDE 71. IT IS POSSIBLE THAT THE DISSECTION MAY HAVE BEEN CAUSED BY TREVO'S PULL/TRACTION. CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER (STRYKER).¿ NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668712 132CM CEREGLIDE 71 CATHETER CATHETER, ASPIRATION CATHETER QJP CERENOVUS, INC. 31214452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H TREVO TRAK¿ MICROCATHETER (STRYKER).| TREVO® STENT RETRIEVER (STRYKER).