BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE

    MDR report key: 7272077 · Received February 14, 2018

    Report

    Report Number
    3005168196-2018-00346
    Event Type
    Death
    Date Received
    February 14, 2018
    Date of Event
    January 16, 2018
    Report Date
    January 16, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548017853
    PMA / PMN Number
    K162901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISPOSED OF BY THE HOSPITAL AND IS NO LONGER AVAILABLE FOR RETURN. 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. POTENTIAL ADVERSE EVENTS WITH THE PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AS NOTED IN THE DEVICE LABELING INCLUDE: INTRACRANIAL HEMORRHAGE, VESSEL DISSECTION OR PERFORATION AND DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED VESSEL DISSECTION, SUBARACHNOID HEMORRHAGE AND DEATH WERE POTENTIAL COMPLICATIONS RELATED TO THE USE OF THE PSR3D. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2018-00343; 3005168196-2018-00344; 3005168196-2018-00345.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M3 SEGMENT OF THE INFERIOR BRANCH OF MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT) AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE NEURON MAX DISTALLY IN THE INTERNAL CAROTID ARTERY (ICA) DUE TO THE PATIENT'S TORTUOUS ANATOMY. AFTER THE NEURON MAX WAS PLACED, THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WAS ADVANCED OVER THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND GUIDEWIRE, INTO THE M2 INFERIOR SEGMENT OF THE MCA. THE GUIDEWIRE WAS THEN REMOVED AND THE PSR3D WAS ADVANCED THROUGH THE 3MAX. NEXT, THE PSR3D WAS DEPLOYED IN THE M3 SEGMENT OF THE MCA AND UPON DEPLOYMENT, BLOOD FLOW WAS OBSERVED DISTAL TO THE PSR3D. ADDITIONALLY, THERE WAS LARGE PLAQUE OBSERVED IN THE VESSEL WHERE THE PSR3D WAS DEPLOYED. THE PLAQUE WAS LOCATED ON THE OUTER MARGIN OF THE PSR3D BETWEEN THE MID TO DISTAL SECTION OF THE DEVICE. THE PSR3D WAS LEFT DEPLOYED FOR FIVE MINUTES, THEN WITHDRAWN BY THE PHYSICIAN. DURING WITHDRAWAL, THE PHYSICIAN EXPERIENCED SUBSTANTIAL RESISTANCE AND CONTINUED APPLYING CONSTANT PULLING FORCE ON THE PSR3D WIRE. SUBSEQUENTLY, THE PSR3D RELEASED FROM THE DEPLOYMENT LOCATION AND WAS PULLED BACK TO THE M2 SEGMENT AND PARTIALLY INTO THE ACE68. THE ACE68 AND PSR3D WERE THEN REMOVED TOGETHER. UPON REMOVAL, THE PHYSICIAN OBSERVED A FEW SMALL BITS OF CLOT ON THE PSR3D AND SAID THAT THE PSR3D APPEARED TO BE IN GOOD WORKING ORDER. AN ANGIOGRAPHIC RUN WAS PERFORMED AND SHOWED THAT THE VESSEL WAS STILL OCCLUDED. AT THIS TIME, THE PHYSICIAN OBSERVED SOME IRREGULARITIES AT THE DISTAL TIP OF THE ACE68 AND OPTED TO OPEN A NEW KIT. THE 3MAX AND GUIDEWIRE WERE THEN LOADED INTO THE NEW ACE68 AND THE PHYSICIAN ATTEMPTED TO INSERT THE SYSTEM INTO THE EXISTING NEURON MAX; HOWEVER, THE PHYSICIAN NOTICED A KINK AT THE HUB OF THE NEURON MAX AND THEREFORE, THE NEURON MAX WAS REMOVED AND REPLACED WITH A NEW ACCESS CATHETER. NEXT, THE ACE68 SYSTEM (ACE68, 3MAX AND GUIDEWIRE) WAS INSERTED INTO THE ACCESS CATHETER AND ADVANCED UP TO THE M2 SEGMENT OF THE MCA. THE ACE 68 WAS THEN ADVANCED MORE DISTAL INTO THE M2 THAN DURING THE FIRST PASS. THE GUIDEWIRE WAS REMOVED AND THE PSR3D WAS ADVANCED THROUGH THE 3MAX TO A LOCATION MORE DISTAL THAN THE FIRST PSR3D DEPLOYMENT. THE 3MAX WAS REMOVED, AND THE PLAQUE WAS OBSERVED AT THE OUTER MARGIN OF THE PROXIMAL SEGMENT OF THE PSR3D, BETWEEN PROXIMAL MARKERS 1 AND 2 OF THE 4 MARKERS. BLOOD FLOW WAS AGAIN OBSERVED DISTAL TO THE PSR3D. THE PHYSICIAN WAITED FIVE MINUTES BEFORE WITHDRAWING THE PSR3D. UPON WITHDRAWAL OF THE PSR3D, THE PHYSICIAN FELT SIGNIFICANT RESISTANCE AND APPLIED ADDITIONAL AND INCREASING PULLING FORCE TO THE PSR3D WIRE UNTIL THE PSR3D MOVED IN THE DIRECTION OF THE ACE68 TIP. THE PSR3D WAS PULLED INTO THE ACE68 AND BOTH THE ACE68 AND PSR3D WERE REMOVED TOGETHER. FOLLOWING THE REMOVAL OF THE ACE68, SOME IRREGULARITIES WERE OBSERVED AT THE TIP OF THE ACE68, SIMILAR TO THE IRREGULARITIES OBSERVED ON THE ACE68 FROM THE FIRST PASS. THE PHYSICIAN ALSO REMARKED THAT THE PSR3D DEVICE APPEARED NORMAL AND FUNCTIONAL. AFTER REMOVING THE ACE68 AND PSR3D, THE PHYSICIAN PERFORMED AN ANGIOGRAPHIC RUN, WHICH REVEALED EXTRAVASATION AND VESSEL DEFORMITY AT THE LOCATION OF THE PLAQUE LESION. IT APPEARED THAT THE PSR3D COUPLED WITH THE PLAQUE AND THAT THE VESSEL DISSECTED OR SEVERED AT THE PLAQUE LOCATION. FOLLOWING THE AFOREMENTIONED OBSERVATION, THE PHYSICIAN ENDED THE PROCEDURE AND THE PATIENT WAS PUT ON A VENTILATOR OVERNIGHT. IT WAS REPORTED THAT THE PATIENT DEVELOPED A SUBARACHNOID HEMORRHAGE RESULTING FROM THE DISSECTED/TORN VESSEL. THE FOLLOWING DAY, THE PATIENT WAS EXTUBATED, AND SHORTLY AFTER, EXPIRED. THE OFFICIAL CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114453 PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE NRY NRY PENUMBRA, INC. F79462 00814548017853

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| L| R