BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2781408 · Received October 10, 2012

    Report

    Report Number
    1058196-2012-00381
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2011
    Report Date
    September 18, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION, THERE WAS NO EVENT OR PRODUCT MALFUNCTION ASSOCIATED WITH THE DEVICE, AND THEREFORE DOES NOT MEET THE CRITERIA FOR REPORTING. ADDITIONALLY, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    THE REPORT FROM (B)(4) STUDY INDICATED THAT THE INDEX PROCEDURE TOOK PLACE 18 MONTHS AGO. THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH VRD (B)(4) OF LEFT PARACELLAR. SIX MONTHS AFTER; THE PATIENT HAD AN EPISODE OF CEREBRAL INFARCTION OF LEFT PARACELLAR AND DEVELOPED A RIGHT-SIDED PARALYSIS. THE ADMINISTRATION OF CLOPIDOGREL SULFATE WAS RE-STARTED. THE EVENT OUTCOME SEVEN MONTHS AFTER THE INDEX PROCEDURE WAS "RESOLVED WITHOUT SEQUEALE". ACCORDING TO THE PHYSICIAN THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNK. THE PATIENT HAD MEDICAL HISTORIES OF CARDIOVASCULAR DISEASE, GASTRIC ULCER, HYPERTENSION AND ABNORMAL CARDIAC RHYTHM. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 7.4MM, AND THE NECK TO SAC RATIO WAS 7.4:10.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.3MM AND DISTALLY WAS 2.8MM. MR ON REMAINED AT 0. THE ACT WAS 106 SECONDS PRE ANTICOAGULATION AND 219 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 80% AFTER THE PROCEDURE. IT IS UNKNOWN WHY THE ANEURYSM WAS NOT PACKED FURTHER. AT THE TIME OF FOLLOW-UP ANGIOGRAM, THE ANEURYSM NECK WAS 7.1MM, AND THE NECK TO SAC RATIO WAS 7.1:11.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.2MM AND DISTALLY WAS 2.7MM. THE OCCLUSION RATE OF ANEURYSM WAS 95%, MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: ONGOING, CLOPIDOGREL SULFATE 75MG/DAY: ONGOING, HEPARIN 4,000U WAS ADMINISTERED INTRA-PROCEDURALLY. PRIOR TO IMPLANTING THE VRD, LANCHER/MEDTRONIC, 606-S255X (LOT UNKNOWN), CHIKAI/ASAHI INTEC. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10, TWO CHIKAI/ASAHI INTEC, (B)(4), THREE V-TRACK/TERUMO, AND SEVEN GDC/STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15244102

    Patients

    Seq Age Sex Outcome Treatment
    1