BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 4910433 · Received July 13, 2015

    Report

    Report Number
    2954740-2015-00162
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    May 3, 2013
    Report Date
    July 22, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT INFORMATION PROVIDED BY THE STUDY INDICATED COIL ((B)(4)) WAS NOT ASSOCIATED WITH THE EVENT (SAH ), THEREFORE THE DEVICE DOES NOT MEET THE CRITERIA FOR REPORTING. THE UNIT ((B)(4)) INVOLVED IN THE EVENT WAS REPORTED UNDER MDR# (B)(4). NO FURTHER INFORMATION WILL BE FORTHCOMING FOR THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REST OF THE INFORMATION HAS BEEN REQUESTED. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE (B)(4) STUDY REPORTED FOR PATIENT WITH (B)(6) THAT DURING THE DEPLOYMENT OF THE 3RD CODMAN TRUFILL COILS, A PERFORATION OF THE ANEURYSM SAC HAS BEEN OBSERVED, CAUSING A SUBARACHNOID HEMORRHAGE (SAH). THE SAH HAS BEEN IMMEDIATELY STOPPED DURING THE PROCEDURE WITH THE BALLOON AND ADDITIONAL COILS WERE USED. THE DEVICE USED DURING THE PROCEDURE CONSISTED ON 1 UNIT C. GALAXY COMPLEX XTRA 3,5MMX7,5 (225133) NUM LOT : 15727743/ 640CX3575 10886704030706, 1 UNIT C. GALAXY COMPLEX FILL 5MMX15 (225150) NUM LOT : 15700136/ 640CF0515 10886704030300, AND 1 UNIT C. CERECYTE 10 PRESIDIO 06X260MM (183491) NUM LOT : C16535 00878528003021. NO OTHER DEVICES WERE ASSOCIATED WITH THE SUBARACHNOID HEMORRHAGE, AND ALL GUIDELINES WERE FOLLOWED DURING DELIVERY OF THE DEVICE. DURING THE EVENT, A REMODELING BALLOON, HYPERGLIDE 4 X 15MM, WAS KEPT INFLATED AND COILING CONTINUED UNTIL BLEEDING HAD BEEN STOPPED. HEPARIN WAS REVERSED BY THE ANESTHETIST BY INTRAVENOUS INJECTION OF PROTAMINE SULFATE. DURING THE EVENT, A SLIGHT, ADDITIONAL FORCE WAS APPLIED TO MAKE THE DISTAL PORTION OF THE THIRD COIL ADVANCE INTO THE ANEURYSM. A CT SCAN WAS PERFORMED AT THE END OF THE PROCEDURE, SHOWING A GRADE FISHER 4 SUBARACHNOID HEMORRHAGE. A CONTROL CT WAS DONE 3 DAYS LATER, SHOWING THE NEARLY COMPLETE RESOLUTION OF THE BLEEDING. THERE WAS NO DISABILITY REPORTED WITH THE EVENT AND NO CLINICAL SIGNIFICANCE. THE EVENT WAS CONSIDERED SERIOUS ADVERSE EVENT AND LIFE THREATENING. THE EVENT WAS HIGHLY PROBABLE TO THE EVENT AND POSSIBLE RELATED TO THE TRUFILL COILS, BUT UNRELATED TO THE DISEASE. ANGIOGRAPHY WAS CONDUCTED AFTER THE PROCEDURE. THE TARGET SITE WAS THE POSTERIOR COMMUNICATING ARTERY DISCOVERED WITHOUT SYMPTOM. TREATMENT WAS CONDUCTED WITH MORE OR EQUAL TO 70% TRUFILL COIL AND USED ADDITIONAL TECHNIQUE. THE RESULTS WERE SATISFACTORY, BUT SAH WAS OBSERVED DURING THE COILING PROCEDURE. THERE WAS 100% OCCLUSION OF THE ANEURYSM WITH SATISFACTORY RESULTS WITH COMPLETE OCCLUSION. THE PATIENT WAS DISCHARGED NINE DAYS AFTER INDEX PROCEDURE. THIRTY DAY FOLLOW-UP WAS CONDUCTED WITH NO ADVERSE EVENT REPORTED, ALSO THE ONE YEAR REPORT WAS CONDUCTED WITHOUT SYMPTOMS NO ADVERSE EVENT. ANGIOGRAPHY AT ONE YEAR SHOWED COMPLETE OCCLUSION 100% COMPARE TO INDEX PROCEDURE, AND NO RECANALIZATION. THE PATIENT COMPLETED THE STUDY. MEDICATIONS CONSISTED OF PRE-PROCEDURE OF EFFEXOR, SERESTA, AND POST PROCEDURE WITH LISANXIA 10MG, VENLAFANXINE 75,MG, CONTRAMAL 100MG, AND DOLIPRANE 500MG. RIGHT POSTERIOR COMMUNICATING ARTERY, HEIGHT 7.8MM NECK 4 MM, NON RUPTURED, PROCEDURE DESCRIPTION : COILS PLACEMENT WITH BALLOON REMODELING TECHNIQUE, COMPLETE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452505 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC C16535

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R