BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR

    MDR report key: 1878330 · Received October 14, 2010

    Report

    Report Number
    1057129-2010-00037
    Event Type
    Injury
    Date Received
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    POREX SURGICAL
    Product Code
    JOF
    PMA / PMN Number
    K083621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR LOT NUMBER 89020-MCI-115-09 (B)(4) WAS REVIEWED AND ALL PROCESSING AND TEST CRITERIA ARE WITHIN THE MEPDOR IMPLANT SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THE PATIENT RECEIVED A MEDPOR CUSTOMIZED IMPLANT THAT DID NOT CONFORM WELL TO THE TEMPORAL REGIONS OF THE SKULL. THE DOCTOR STATED THAT HE TRIED TO MOLD/TRIM BUT THE POST OP APPEARANCE WAS NOT THAT PLEASANT. THE DOCTOR STATED THAT THERE IS A LARGE STEP OFF BETWEEN THE LATERAL EDGES AND THE CRANIUM BI TEMPORALLY. DEVICE NOT RETURNED

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE PT RECEIVED A MEDPOR FRONTAL CRANIAL IMPLANT. THE DOCTOR REPORTED THAT THE PT DEVELOPED A SHUNT INFECTION THAT LEAD TO THE REMOVAL OF THE IMPLANT. THE DOCTOR STATED THAT THERE WAS NO ISSUE WITH THE IMPLANT AND THE PT IS DOING FINE.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) REGISTRY, APPROXIMATELY A MONTH POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. EIGHT MONTHS POST-PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT IS A AN (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(6) STUDY FOR STENTING OF THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2009. THE RATE OF STENOSIS IS 86%. AN ANGIOGUARD (601814RMC / LOT 70209537) DISTAL PROTECTION DEVICE WAS DEPLOYED DISTAL IN THE VESSEL AND THE LESION WAS PRE-DILATED. A PRECISE (PC0730RXC/ LOT 14003079) STENT WAS DEPLOYED IN THE LESION. THERE WAS NO MALFUNCTION WITH THE STENT. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THREE DAYS LATER. APPROXIMATELY ONE MONTH POST INDEX PROCEDURE, THE PATIENT EXPERIENCED HEMIPARESIS ON THE LEFT SIDE. ONSET WAS GRADUAL. DIAGNOSIS WAS A STROKE. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. APPROXIMATELY EIGHT MONTHS POST PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR MEDPOR CUSTOMIZED SURGICAL IMPLANT JOF POREX SURGICAL NA MCI-11509 E015C33H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other