BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 3133086 · Received May 29, 2013

    Report

    Report Number
    1226348-2013-20097
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 9, 2011
    Report Date
    May 6, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K062036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. MEDICATIONS GIVEN DURING THE PROCEDURE CONSISTED OF 20 MG VERAPAMIL WAS ADMINISTRATED INTO THE LEFT A1, AND 15 MG REOPRO. CONCOMITANT PRODUCTS: PRODUCT USED DURING THE PROCEDURE CONSISTED OF A TRANSCEND SOFT-TIP, 6F CHAPERON, SL CATHETER, AND ASCENT BALLOON. ANEURYSM RECURRENCE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. THESE PROCEDURES ARE PERFORMED IN EXISTING ANEURYSMS AND KNOWN VESSEL WALL WEAKNESS. ALTHOUGH THE RELATIONSHIP OF THE MICROCOILS TO THE EVENT CANNOT BE CONCLUSIVELY EXCLUDED; AS REPORTED, THE EVENT IS NOT ATTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE OF ANY MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTING TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. (B)(4).

    Description of Event or Problem · 1

    THE (B)(6) STUDY INDICATED THAT SUBJECT (B)(6) HAD A FOLLOW-UP CT SCAN PERFORMED 19 MONTHS SHOWED RECURRENCE OF THE PREVIOUSLY TREATED ACOM ANEURYSM WITH CODMAN COILS (PRESIDIO MICROCOIL (PC181034-30/F46107, CASHMERE MICROCOILS (CRC140717-30/F41363, CRC14071730/F45683, CRC14061530/F52738, CRC14040830/F53521, CRC14040830/F53521, AND CRC14040830/F53521) AND ULTIPAQ MICROCOILS (CFS100306-30/F31143, CFS100204-30/F50680, AND CFS100203-30/F52770). DIAGNOSTIC ANGIOGRAPHY AND INTERVENTION WAS INDICATED. THE NON CODMAN COILS (AXIUM 4X80MM, AXIUM 3MM X8OMM, AXIUM 3MMX60MM), HYDROSOFT 2.5MMX6MM, HYDROSOFT 2.0 MMX6MM, AXIUM 2MMX4MM), WERE SUCCESSFULLY DEPLOYED WITH INTERMITTENT BALLOON INFLATION. THERE WAS NO EVIDENCE OF SIGNIFICANT COIL INSTABILITY DURING THE EMBOLIZATION. FOLLOWING COIL EMBOLIZATION, THERE WAS COMPLETE OCCLUSION OF THE ANEURYSM. CONTROL ANGIOGRAPHY FOLLOWING AN EMBOLIZATION DEMONSTRATED NO EVIDENCE OF BRANCH VESSEL OCCLUSION. OTHER COMPLICATIONS WERE NOT REPORTED. AFTER RETREATMENT, THE FINAL ANGIOGRAPHIC SCORE WAS RAYMOND ROY GRADE 2 (RESIDUAL FILLING OF ANEURYSM NECK). PI INDICATED THAT THE EVENT WAS POSSIBLE RELATED TO THE STUDY DEVICE, NOT TO THE PROCEDURE, AND THE MEDICAL MONITOR INDICATED THAT THE EVENT WAS POSSIBLE RELATED TO THE STUDY DEVICE NOT TO THE PROCEDURE. DURING THE INDEX PROCEDURE, DIAGNOSTIC CT SCAN SHOWED EVIDENCE OF A 9.4 MM X 8.3MM X 4MM RUPTURED ANEURYSM ARISING FROM THE JUNCTION OF THE ANTERIOR COMMUNICATING ARTERY AND THE LEFT ANTERIOR CEREBRAL ARTERY WITH A WFNS GRADE 1. THE SUBJECT PRESENTED WITH SUBARACHNOID HEMORRHAGE (SAH) AND UNDERWENT COILING OF THE ANTERIOR COMMUNICATING ANEURYSM. SUBJECT WAS TREATED WITH 10 CODMAN MICROCOILS (PRESIDIO, CASHMERE X6, AND ULTIPAQ X3). THE ANGIOGRAPHIC SCORE WAS RAYMOND ROY 1 AT END OF INDEX COILING PROCEDURE. A BALLOON WAS USED AS ADJUNCTIVE TECHNIQUE. SUBJECT WAS DISCHARGED APPROXIMATELY 3 WEEKS AFTER THE EVENT WITH A MRS OF 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234235 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F46107

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention