BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEURON MAX

    MDR report key: 8829330 · Received July 25, 2019

    Report

    Report Number
    3005168196-2019-01444
    Event Type
    Death
    Date Received
    July 25, 2019
    Date of Event
    June 26, 2019
    Report Date
    June 26, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012292
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE UPDATED ON THIS FOLLOW-UP #02 MFR REPORT 3005168196-2019-01444: 1. SECTION B. BOX 1. ADVERSE EVENT AND/OR PRODUCT PROBLEM. 2. SECTION B. BOX 2. OUTCOMES ATTRIBUTED TO ADVERSE EVENT; DATE OF DEATH. 3. SECTION H. BOX 1. TYPE OF REPORTABLE EVENT. 4. SECTION H. BOX 6. PATIENT CODE 2. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2019-01443 H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP MFR REPORT: DESCRIBE EVENT OR PROBLEM. RESULTS: THE RETURNED NEURON MAX WAS FOUND KINKED AT APPROXIMATELY 88.5CM FROM THE HUB, AND MINOR DAMAGE WAS OBSERVED AT APPROXIMATELY 111.0CM FROM THE HUB. THE TOTAL LENGTH OF THE DEVICE IS APPROXIMATELY 113.5CM. THE DISTAL PORTION OF THE JET7 WAS STUCK INSIDE THE NEURON MAX AT THE KINK. CONCLUSIONS: EVALUATION OF THE RETURNED JET7 CONFIRMED A STRETCHED AND FRACTURED DEVICE. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE ADVANCING AND RETRACTING THE JET7. IF THE JET7 IS FORCEFULLY RETRACTED AGAINST RESISTANCE, IT MAY BEGIN TO STRETCH AND EVENTUALLY FRACTURE. THE DISTAL PORTION OF THE JET7 WAS STUCK INSIDE THE NEURON MAX, AT THE KINKED LOCATION. THE NEURON MAX KINK LIKELY CONTRIBUTED TO THE RESISTANCE EXPERIENCED DURING THE PROCEDURE WHILE ADVANCING AND RETRACTING THE JET7. EVALUATION OF THE RETURNED NEURON MAX CONFIRMED A KINK. DURING FUNCTIONAL TESTING, A DEMONSTRATION MANDREL WAS UNABLE TO PASS THROUGH THE KINK DUE TO THE REMAINING DISTAL PORTION OF THE JET7 BEING STUCK INSIDE THE LUMEN OF THE NEURON MAX. THE ROOT CAUSE OF THE NEURON MAX KINK WAS UNABLE TO BE DETERMINED. A KINKED DEVICE WILL LIKELY RESULT IN ADDITIONAL RESISTANCE WHEN ADVANCING OR RETRACTING DEVICES THROUGH IT. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2019-01443.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE JET7 AND VELOCITY THROUGH THE NEURON MAX. AFTER COMPLETING TWO PASSES, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE ADVANCING AND RETRACTING THE JET7 AND SUBSEQUENTLY THE JET7 FRACTURED. THE NEURON MAX CONTAINING THE BROKEN JET7 WAS REMOVED FROM THE PATIENT. UPON REMOVAL OF THE NEURON MAX, A KINK WAS OBSERVED. THE PROCEDURE WAS CONCLUDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT THEN LATER EXPIRED; HOWEVER, THE CAUSE OF DEATH IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2019-01443.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE JET7 AND VELOCITY THROUGH THE NEURON MAX. AFTER COMPLETING TWO PASSES, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE ADVANCING AND RETRACTING THE JET7 AND SUBSEQUENTLY THE JET7 FRACTURED WITHIN THE PATIENT'S VESSEL. THE NEURON MAX CONTAINING THE BROKEN JET7 WAS REMOVED AND THE TIP OF THE JET7 WAS LEFT IN THE M1 ARTERY. UPON REMOVAL OF THE NEURON MAX, A KINK WAS OBSERVED. THE PROCEDURE WAS CONCLUDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT PASSED AWAY; HOWEVER, THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. FURTHERMORE, THE RELATIONSHIP BETWEEN THE FRACTURED JET7 TIP AND DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622486 NEURON MAX NRY NRY PENUMBRA, INC. PNML6F0881004 F77031 00814548012292

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death