BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 9099004 · Received September 20, 2019

    Report

    Report Number
    3005168196-2019-01795
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    April 5, 2019
    Report Date
    August 23, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012216
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE NEURON MAX SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, VESSEL SPASM, THROMBOSIS, DISSECTION OR PERFORATION, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, AFTER PLACING THE NEURON MAX IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THERE WAS POOR ASPIRATION WHILE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN FOUND THE DISTAL END OF THE NEURON MAX TO BE KINKED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX WITH THE SAME JET7 AND MICROCATHETER. IT WAS REPORTED THAT THE PATIENT EXPERIENCED VASOSPASM IN THE ICA AND WAS TREATED WITH 100 MICROGRAM OF INTRA-ARTERIAL NITROGLYCERIN; HOWEVER, THE VASOSPASM IS UNRELATED TO ANY PENUMBRA DEVICES USED IN THE INDEX PROCEDURE. SUBSEQUENTLY, THE PHYSICIAN PERFORMED AN ANGIOGRAM THAT REVEALED A SMALL FILLING THROMBUS IN THE PROXIMAL PETROUS PORTION OF THE ICA. WHILE MAKING THE FINAL PASS, THE PHYSICIAN ADVANCED THE JET7 TO THE LEVEL OF THE FILLING OF THROMBUS AND ADDITIONAL ASPIRATION WAS PERFORMED. ANOTHER ANGIOGRAM WAS PERFORMED AND REVEALED A CLEARING OF FILLING DEFECT BUT A RESIDUAL NONFLOW LIMITING DISSECTION WAS IDENTIFIED. IT WAS ALSO REPORTED AT, THAT MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) 3 WAS ACHIEVED AND NO FURTHER INTERVENTION WAS CONDUCTED. THE PROCEDURE WAS COMPLETED AT THIS POINT AND THE PATIENT WAS TRANSFERRED TO DEDICATED STROKE UNIT. IN THE STROKE UNIT ON DAY ONE POST-PROCEDURE, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS DOWN TO 7 VERSUS 35 AT ADMISSION. DUAL ANTIPLATELET MEDICATION WAS STARTED. ON DAY THREE POST-PROCEDURE, PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY ON DUAL ANTIPLATELET MEDICATION. PATIENTS NIHSS WAS FURTHER DOWN TO 3. ON DAY 38 POST-PROCEDURE, PATIENT WAS AT HOME WITHOUT ANY OUTPATIENT CARE SUPPORT WITH MODIFIED RANKIN SCALE (MRS) OF 1 AND REMAINED UNCHANGED ON DAY 83 POST-PROCEDURE WHEN PATIENT EXITED THE STUDY. ON 19-FEB-2019, THE INTRACRANIAL VESSEL DISSECTION WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT RELATED TO THE NEURON MAX AND INDEX PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, AFTER PLACING THE NEURON MAX IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THERE WAS POOR ASPIRATION WHILE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN FOUND THE DISTAL END OF THE NEURON MAX TO BE KINKED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX WITH THE SAME JET7 AND MICROCATHETER. IT WAS REPORTED THAT THE PATIENT EXPERIENCED VASOSPASM IN THE ICA AND WAS TREATED WITH 100 MICROGRAM OF INTRA-ARTERIAL NITROGLYCERIN; HOWEVER, THE VASOSPASM IS UNRELATED TO ANY PENUMBRA DEVICES USED IN THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890589 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. PNML6F088804 F87219 00814548012216

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization