BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASHMERE 14 - PLATINUM MICROCOIL

    MDR report key: 6049592 · Received October 23, 2016

    Report

    Report Number
    2954740-2016-00252
    Event Type
    Injury
    Date Received
    October 23, 2016
    Date of Event
    July 3, 2016
    Report Date
    September 29, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K072173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: UNSPECIFIED STENT, ONE DELTAPAQ COIL, THREE CASHMERE COILS, AND A COMPLEX FILL COIL. SINCE THE LOT NUMBER IS UNKNOWN, THE MANUFACTURING AND LOT NUMBER WERE UNKNOWN. CONCLUSION: THE DEVICES WERE IMPLANTED AND NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBERS WERE NOT AVAILABLE; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. ANEURYSM RECANALIZATION/COIL COMPACTION AFTER COIL EMBOLIZATION IS A KNOWN EVENT ASSOCIATED WITH INTRACRANIAL COIL PLACEMENT. FACTORS WHICH MAY HAVE A CORRELATION WITH RECANALIZATION/COIL COMPACTION POST COIL EMBOLIZATION INCLUDE NECK SIZE, PACKING DENSITY, AND INFLOW ANGLE. HEMORRHAGE STROKE AND SUBARACHNOID HEMORRHAGE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF INTRACRANIAL STENTS AND COILS. THE INHERENT RISK OF INTRODUCING DEVICES INTO THE DELICATE CEREBRAL VESSELS AS WELL AS THE CHANGES IN INTRACRANIAL PRESSURES AND ANATOMY POST COIL PLACEMENT WITHIN THE ANEURYSM CAN CONTRIBUTE TO THE OCCURRENCE OF INTRACRANIAL HEMORRHAGE. THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT. THIS IS 1 OF 5 MDR REPORTS SUBMITTED FOR THIS COMPLAINT, WITH ASSOCIATED REPORT NUMBERS OF 1226348-2016-00154, 2954740-2016-00250, 2954740-2016-00251, 2954740-2016-00252, 2954740-2016-00253.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, FOLLOWING COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM, THERE WAS RE-BUILDUP OF CEREBRAL ANEURYSM APPROXIMATELY THREE YEARS AND 2 MONTHS AFTER IMPLANTATION OF A DELTAPAQ COIL, THREE CASHMERE COILS, AND A COMPLEX FILL COIL (CATALOG AND LOT NUMBERS UNKNOWN). THE COILS HAD INITIALLY BEEN IMPLANTED WITH STENT SUPPORT DUE TO PRIOR RECANALIZATION. THE ORIGINAL COILS IMPLANTED WERE UNKNOWN. THREE YEARS AND 2 MONTHS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SUBARACHNOID HEMORRHAGE DUE TO RE-BUILD-UP OF CEREBRAL ANEURYSM WHICH WAS CONFIRMED DURING ROUTINE FOLLOW-UP. MODIFIED RANKIN SCORE PRIOR TO COIL IMPLANTATION WAS GRADE 5. THE PATIENT RECOVERED AFTER ADDITIONAL COIL EMBOLIZATION WAS PERFORMED. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700812 CASHMERE 14 - PLATINUM MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R