BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2770401 · Received October 3, 2012

    Report

    Report Number
    3005168196-2012-00309
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    December 24, 2008
    Report Date
    February 11, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. AS THIS PATIENT WAS ENROLLED IN THE POST-MARKET STUDY, (B)(6), THE EVENT WAS NOT DISCOVERED UNTIL LATER DATA COLLECTION AND THE SPONSOR REVIEWED THE FINAL DATA ENTRY DISCREPANCIES DURING STUDY CLOSE OUT. FINAL CLARIFICATION OF THE EVENT AND RELATIONSHIP TO THE SYSTEM WAS EVALUATED AND THE RELATIONSHIP TO THE DEVICE REMAINS "UNCERTAIN". EVAL SUMMARY: DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    (B)(4) WAS TREATED FOR AN ICA SUPRACLINOID OCCLUSION ON (B)(6) 2008. THE VESSEL WAS SUCCESSFULLY OPENED TO A TIMI 2 WITH THE PENUMBRA SYSTEM, AND THE PROCEDURE WAS TERMINATED WITHOUT INCIDENT. FOLLOW UP IMAGING REVEALED AN ASYMPTOMATIC PETECHIAL HEMORRHAGE IN THE RIGHT BASAL GANGLIA. ALTHOUGH THIS EVENT HAS BEEN REPORTED AS AN SAE IN (B)(6), THE PHYSICIAN HAS RATED THE EVENT AS BEING MILD IN SEVERITY, WITH AN UNCERTAIN RELATIONSHIP TO THE PENUMBRA SYSTEM. THE PETECHIAL HEMORRHAGE DID NOT REQUIRE MEDICAL INTERVENTION AND RESOLVED ON (B)(6) 2009. AFTER THE EVENT WAS REPORTED IN (B)(6) ON (B)(6) 2010, AN EMAIL COMMUNICATION WAS SENT TO DR. (B)(6) TO EXPLAIN THE RELATIONSHIP BETWEEN THE PETECHIAL HEMORRHAGE AND THE PENUMBRA SYSTEM (GIVEN THE 'UNCERTAIN' RELATIONSHIP REPORTED IN (B)(4)). IN RESPONSE, ON (B)(6) 2010, DR. (B)(6) EXPLAINED, 'REGARDING THE REFERENCED (B)(4) BELOW, THERE WERE CT AND MRI EXAMS PERFORMED AFTER THE THROMBECTOMY PROCEDURE THAT SHOWED BLOOD IN THE RIGHT BASAL GANGLIA. THIS IS ALMOST CERTAINLY HEMORRHAGE INTO INFARCTED BRAIN PARENCHYMA. THE BASAL GANGLIA AREA WAS ABNORMAL ON CBV CT PERFUSION IMAGING PRE-PROCEDURE, SUGGESTING THERE WAS COMPLETED INFARCT IN THE BASAL GANGLIA BEFORE THE PROCEDURE WAS STARTED. AS WITH ANY HEMORRHAGE THAT OCCURS AFTER AN ENDOVASCULAR STROKE RESCUE, ONE CAN'T COMPLETELY EXCLUDE A RELATIONSHIP TO THE PROCEDURE OR DEVICE, BUT I BELIEVE THE HEMORRHAGE WOULD BE VERY UNLIKELY RELATED TO THE STUDY DEVICE.' ON (B)(6)2009, THE PATIENT WAS NOTED AS RESIDING AT HOME WITH A NIHSS SCORE OF 2, AND A MRS OF 3. THIS EVENT WAS ORIGINALLY REPORTED TO QUALITY ON (B)(6) 2010. AT THAT TIME THE RELATIONSHIP BETWEEN THE EVENT AND THE PENUMBRA SYSTEM WAS NOT CLEAR DUE TO A DISCREPANCY BETWEEN THE OPINION OF THE TREATING PHYSICIAN'S AT THE HOSPITAL. WHEN THE DATA WAS REVIEWED IN (B)(6) 2012 AT THE CLOSE OF THE STUDY, THE CLINICAL (B)(6) ENTRY FOR THIS EVENT WAS REVIEWED AND NO CHANGES IN THE ORIGINAL DECISION HAD BEEN MADE DURING SITE CLOSE-OUT THEREFORE THE POSSIBLE RELATIONSHIP TO THE STUDY DEVICE AS DESCRIBED ABOVE STILL STANDS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00306--310.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other