BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 026

    MDR report key: 1604241 · Received February 9, 2010

    Report

    Report Number
    3005168196-2010-00094
    Event Type
    Other
    Date Received
    February 9, 2010
    Date of Event
    April 17, 2009
    Report Date
    May 5, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS REPORTED BY THE HOSPITAL AS A PART OF THE (B)(4) CLINICAL TRIAL PICS. THE INFORMATION THAT WAS INITIALLY REPORTED DID NOT INDICATE AN INCIDENT THAT WOULD REQUIRE THE SUBMISSION OF AN MDR. HOWEVER, INFORMATION RECEIVED FROM THE PHYSICIAN IN A FOLLOW-UP REPORT ON (B)(6) 2010 STATED THAT ALTHOUGH THERE WAS NO VERIFIABLE EVIDENCE IN PROCEDURAL SCANS, A SAH OF THIS NATURE COULD NOT BE CAUSED BY ANYTHING ELSE OTHER THAN A PERFORATION; AND BECAUSE, THE SAH APPEARED AFTER THE USE OF THE PENUMBRA SYSTEM, THE RELATIONSHIP BETWEEN THE SAH AND THE DEVICE IS POSSIBLE.

    Description of Event or Problem · 1

    PICS PATIENT WAS ADMITTED WITH AN OCCLUSION OF THE M2 MCA. AFTER BEING REFRACTORY TO IV TPA, 4.5MG OF IA TPA WAS ADMINISTERED AT THE SITE OF THROMBUS. MINIMAL THROMBOLYSIS WAS OBSERVED DURING FOLLOW-UP ANGIOGRAPHY, AND THE PHYSICIAN ELECTED TO PROCEED WITH CLOT-ASPIRATION USING A PENUMBRA 026 REPERFUSION CATHETER. UNDER ROADMAP GUIDANCE, THE PHYSICIAN WAS ABLE TO OPEN THE VESSEL TO A TIMI 2. ADDITIONAL POST-PROCEDURAL IMAGING REVEALED A SMALL SUB-ARACHNOID HEMORRHAGE (SAH) IN THE LEFT SYLVIAN FISSURE. THE PHYSICIAN BELIEVED THAT THE SAH WAS POSSIBLE RELATED TO EITHER THE ANGIOGRAPHIC PROCEDURE OR THE DEVICE, HOWEVER, THERE WERE NO REPORTS OF VESSEL PERFORATION OR DISSECTION IN THE HOSPITAL'S PROCEDURAL DOCUMENTS. THE SAH WAS ALSO JUDGED TO BE SMALL AND ASYMPTOMATIC BY THE PHYSICIAN, AND DID NOT PROMPT ADDITIONAL MEDICAL INTERVENTION. AT 24 HOURS POST-PROCEDURE, IMAGING SHOWED SUBSTANTIAL IMPROVEMENT OF THE SAH, AND THE PATIENT WAS DISCHARGED TO ACUTE REHAB WITHIN FOUR DAYS. BY (B)(6) POST-PROCEDURE, THE SAH HAD RESOLVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. THIS EVENT WAS RATED AS A NON-SERIOUS ADVERSE EVENT BY THE PHYSICIAN AND THE PATIENT EVENTUALLY RETURNED HOME. BY (B)(6), THE PATIENT WAS NOTED AS LIVING AT HOME WITH A MODIFIED RANKIN SCALE OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 026 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR