BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA

    MDR report key: 1845160 · Received September 14, 2010

    Report

    Report Number
    1845160
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 14, 2010
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A MIDDLE-AGED WOMAN WITH LITTLE MEDICAL HISTORY AND APPARENTLY NO MEDICATIONS PREVIOUSLY, WHO PRESENTED TO THE EMERGENCY ROOM LAST MONTH WITH SYMPTOMS OF ACUTE CVA. SHE WAS EVALUATED EMERGENTLY PER THE CODE STROKE PROTOCOL AND GIVEN T-PA FOR HER SYMPTOMS SUGGESTIVE OF ACUTE UNCOMPLICATED STROKE. SHE WAS REFRACTORY TO T-PA AND TAKEN FOR ANGIOGRAPHY AND ATTEMPTED ASPIRATION OF AN MCA DISTRIBUTION CLOT THE FOLLOWING DAY. EACH TIME THE CLOT WAS ASPIRATED, THE AREA RETHROMBOSED, AND ULTIMATELY, THE PROCEDURE WAS ABANDONED. SHE WENT ON TO INFARCT THAT AREA OF HER BRAIN AND DEVELOPED MALIGNANT CEREBRAL EDEMA REQUIRING CRANIECTOMY PROCEDURE, ALSO THIS DAY. THE PATIENT HAS HAD A STORMY HOSPITAL COURSE WITH ISSUES, INCLUDING INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION SYNDROME (SIADH), PLEURAL EFFUSION, HOSPITAL PNEUMONIA, AND WHAT APPEARS TO BE A STATE OF COMA WITH RESPIRATORY FAILURE REQUIRING FULL VENTILATOR SUPPORT. SHE REMAINED ON NOREPINEPHRINE VASOPRESSOR TO MAINTAIN A TARGET MEAN ARTERIAL PRESSURE FOR ADEQUATE PERFUSION OF HER BRAIN UNTIL FAMILY CHOSE TO MAKE THE PATIENT A DNR AND HAVE LIFE SUPPORT REMOVED.AT PATHOLOGIC EXAM, THE PATHOLOGIST NOTED THAT THE PATIENT APPEARS TO HAVE MATERIAL IN THE CEREBRAL VESSEL. THERE HAS BEEN RECENT LITERATURE SUGGESTING THAT HYDROPHILIC POLYMER EMBOLI CAN RESULT FROM DIAGNOSTIC CEREBRAL ANGIOGRAPHY (MODERN PATHOLOGY, (2010)23: 921-930). THE PATHOLOGIST IS QUESTIONING IF THE MATERIAL IN THIS PATIENT'S VESSELS WAS THE RESULT OF POLYMER SHEDDING FROM THE CATHETERS USED DURING THE CRANIAL ANGIO. (SEVERAL CATHETERS AND GUIDEWIRES FROM A VARIETY OF MANUFACTURERS WERE ALSO USED). ====================== HEALTH PROFESSIONAL'S IMPRESSION======================THERE HAS BEEN RECENT LITERATURE SUGGESTING THAT HYDROPHILIC POLYMER EMBOLI CAN RESULT FROM DIAGNOSTIC CEREBRAL ANGIOGRAPHY (MODERN PATHOLOGY, (2010)23: 921-930). THE PATHOLOGIST IS QUESTIONING IF THE MATERIAL IN THIS PATIENT'S VESSELS WAS THE RESULT OF POLYMER SHEDDING FROM THE CATHETERS USED DURING THE CRANIAL ANGIO.====================== MANUFACTURER RESPONSE FOR CRANIAL REPERFUSION CATHETER, PENUMBRA======================THE NEUROINTERVENTIONALIST CONTACTED THE MANUFACTURER AFTER SPEAKING WITH THE PATHOLOGIST REGARDING FINDINGS OF MATERIAL IN THE CRANIAL VESSELS.

    Description of Event or Problem · 1

    THE PATIENT IS A (B) (6) WOMAN WITH LITTLE MEDICAL HISTORY AND APPARENTLY NO MEDICATIONS PREVIOUSLY, WHO PRESENTED TO THE EMERGENCY ROOM LAST MONTH WITH SYMPTOMS OF ACUTE CVA. SHE WAS EVALUATED EMERGENTLY PER THE CODE STROKE PROTOCOL AND GIVEN T-PA FOR HER SYMPTOMS SUGGESTIVE OF ACUTE UNCOMPLICATED STROKE. SHE WAS REFRACTORY TO T-PA AND TAKEN FOR ANGIOGRAPHY AND ATTEMPTED ASPIRATION OF AN MCA DISTRIBUTION CLOT THE FOLLOWING DAY. EACH TIME THE CLOT WAS ASPIRATED, THE AREA RETHROMBOSED, AND ULTIMATELY, THE PROCEDURE WAS ABANDONED. SHE WENT ON TO INFARCT THAT AREA OF HER BRAIN AND DEVELOPED MALIGNANT CEREBRAL EDEMA REQUIRING CRANIECTOMY PROCEDURE, ALSO THIS DAY. THE PATIENT HAS HAD A STORMY HOSPITAL COURSE WITH ISSUES, INCLUDING INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION SYNDROME (SIADH), PLEURAL EFFUSION, HOSPITAL PNEUMONIA, AND WHAT APPEARS TO BE A STATE OF COMA WITH RESPIRATORY FAILURE REQUIRING FULL VENTILATOR SUPPORT. SHE REMAINED ON NOREPINEPHRINE VASOPRESSOR TO MAINTAIN A TARGET MEAN ARTERIAL PRESSURE FOR ADEQUATE PERFUSION OF HER BRAIN UNTIL FAMILY CHOSE TO MAKE THE PATIENT A DNR AND HAVE LIFE SUPPORT REMOVED.AT PATHOLOGIC EXAM, THE PATHOLOGIST NOTED THAT THE PATIENT APPEARS TO HAVE MATERIAL IN THE CEREBRAL VESSEL. THERE HAS BEEN RECENT LITERATURE SUGGESTING THAT HYDROPHILIC POLYMER EMBOLI CAN RESULT FROM DIAGNOSTIC CEREBRAL ANGIOGRAPHY (MODERN PATHOLOGY, (2010)23: 921-930). THE PATHOLOGIST IS QUESTIONING IF THE MATERIAL IN THIS PATIENT'S VESSELS WAS THE RESULT OF POLYMER SHEDDING FROM THE CATHETERS USED DURING THE CRANIAL ANGIO. (SEVERAL CATHETERS AND GUIDEWIRES FROM A VARIETY OF MANUFACTURERS WERE ALSO USED). ====================== HEALTH PROFESSIONAL'S IMPRESSION======================THERE HAS BEEN RECENT LITERATURE SUGGESTING THAT HYDROPHILIC POLYMER EMBOLI CAN RESULT FROM DIAGNOSTIC CEREBRAL ANGIOGRAPHY (MODERN PATHOLOGY, (2010)23: 921-930). THE PATHOLOGIST IS QUESTIONING IF THE MATERIAL IN THIS PATIENT'S VESSELS WAS THE RESULT OF POLYMER SHEDDING FROM THE CATHETERS USED DURING THE CRANIAL ANGIO.====================== MANUFACTURER RESPONSE FOR CRANIAL REPERFUSION CATHETER, PENUMBRA======================THE NEUROINTERVENTIONALIST CONTACTED THE MANUFACTURER AFTER SPEAKING WITH THE PATHOLOGIST REGARDING FINDINGS OF MATERIAL IN THE CRANIAL VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA CATHETER, THROMBUS RETRIEVER NRY PENUMBRA INC. REPERFUSION CATHETER 032 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R OTHER