BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

    MDR report key: 6643161 · Received June 15, 2017

    Report

    Report Number
    3008264254-2017-00080
    Event Type
    Death
    Date Received
    June 15, 2017
    Date of Event
    December 12, 2006
    Report Date
    May 26, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRD
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 3008264254-2017-00080, UDI UNAVAILABLE; CATALOG#/LOT UNKNOWN. CONCOMITANT PRODUCTS: PROWLER MICROCATHETER (CORDIS NEUROVASCULAR) IN CONJUNCTION WITH AN AGILITY 14 (CORDIS NEUROVASCULAR) OR A SYNCHRO 14 MICROWIRE (TARGET THERAPEUTICS/BOSTON SCIENTIFIC, (B)(4)). (B)(4). NEITHER THE CATALOGUE NUMBER NOR THE LOT NUMBER WAS AVAILABLE THUS NEITHER DHR NOR FAL COULD BE COMPLETED. VASOSPASM IS WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ENDOVASCULAR ANEURYSM REPAIR PROCEDURES AND THE USE OF THE CODMAN EMBOLIC OILS AND IS LISTED IN THE IFU AS SUCH. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT UNDERLYING DISEASE PROCESS, SPECIFICALLY THE SIZE /LOCATION OF THE ANEURYSM, PATIENT AGE AND MEDICATION REGIMEN ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVED A DEATH AND THOSE FIELDS WERE ACCIDENTALLY OMITTED.  THEY HAVE BEEN ADDED IN THIS REPORT TO REFLECT THE DEATH EVENT. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COMPLEX-SHAPED PLATINUM COILS FOR BRAIN ANEURYSMS: HIGHER PACKING DENSITY, IMPROVED BIOMECHANICAL STABILITY, AND MIDTERM ANGIOGRAPHIC OUTCOME¿ BY A.K. WAKHLOO, M.J. GOUNIS, J.S. SANDHU, N. AKKAWI, A.E. SCHENCK, AND I. LINFANTE, PUBLISHED AJNR AM J NEURORADIOL 28:1395¿ 400 _ AUG 2007 _ WWW.AJNR.ORG, IT WAS REPORTED THAT THE ADVERSE EVENT VASOSPASM OCCURRED IN THIS (B)(6) FEMALE THAT SUBSEQUENTLY LEAD TO DEATH FROM CEREBRAL ISCHEMIA. PER THE ARTICLE: ¿BACKGROUND AND PURPOSE: FIVE TO 60% OF COILED BRAIN ANEURYSMS RECANALIZE, GENERALLY BECAUSE OF COIL COMPACTION. IN VITRO EXCLUSIVE USE OF COMPLEX-SHAPED COILS ALLOWS BETTER PACKING OF THE ANEURYSMAL SAC AND THE NECK AS COMPARED WITH HELICAL COILS. WE REPORT A SINGLE-CENTER, PROSPECTIVE STUDY USING COMPLEX COILS. SAFETY, PACKING DENSITY, AND RECANALIZATION RATE WERE EVALUATED¿ COMPLICATIONS AND OUTCOME: WITH REGARD TO PERIPROCEDURAL COMPLICATIONS, IN 1 PATIENT WE EXPERIENCED COIL STRETCHING AND DISLOCATION, WITH SUBSEQUENT RETRIEVAL. THE PATIENT DID NOT SUFFER ANY DAMAGE TO THE ARTERIAL SYSTEM AND REMAINED ASYMPTOMATIC. IN ANOTHER PATIENT, WITH A SUPERIOR HYPOPHYSEAL ARTERY ANEURYSM, THE 3-MM COMPLEX FILL COIL WAS PUSHED OUT INTO THE MIDDLE CEREBRAL ARTERY DURING PLACEMENT OF THE SECOND, 2-MM COMPLEX-FILL COIL. THE COIL WAS RETRIEVED SAFELY WITH A SNARE DEVICE, AND THE ANEURYSM WAS SUCCESSFULLY OBLITERATED. PERIPROCEDURAL NON-DEVICE-RELATED DEFICITS WERE SEEN IN 2 PATIENTS OF THE 69 TREATED PATIENTS (2.9%). FIRST, DURING FORCED PLACEMENT OF THE LAST COMPLEX COIL, A FRACTURE OCCURRED AND THE COIL HAD TO BE SURGICALLY REMOVED. SECOND, A RUPTURED ANEURYSM RE-RUPTURED DURING PLACEMENT OF THE MICROCATHETER. THE PATIENT WITH THE FRACTURED COIL WOKE UP FROM SURGERY WITH A PROGRESSIVELY IMPROVING MILD EXPRESSIVE APHASIA. THE PATIENT WITH THE RE-RUPTURED ANEURYSM EXPERIENCED DELAYED NEUROLOGIC RECOVERY. A (B)(6) WOMAN WITH A RUPTURED BASILAR TIP ANEURYSM AND AN (B)(6) WOMAN WITH A POSTERIOR COMMUNICATING ARTERY ANEURYSM, BOTH OF WHOM PRESENTED AS HH GRADE 3, DIED A FEW DAYS AFTER COILING FROM AN EXTENSIVE BRAIN ISCHEMIA RELATED TO SEVERE VASOSPASM.¿ AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425472 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE KRD CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R