BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 TDL COMPLEX FILL COIL 5X10

    MDR report key: 6614832 · Received June 6, 2017

    Report

    Report Number
    3008264254-2017-00071
    Event Type
    Death
    Date Received
    June 6, 2017
    Date of Event
    January 1, 2005
    Report Date
    May 19, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRD
    PMA / PMN Number
    K123560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION FOR MEDWATCH. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 3008264254-2017-00071 AND 3008264254-2017-00072. (B)(4). LITERATURE ARTICLE ¿INFLUENCE OF COIL THICKNESS ON PACKING, RE-OPENING AND RETREATMENT OF INTRACRANIAL ANEURYSMS: A COMPARATIVE STUDY BETWEEN TWO TYPES OF COILS¿ BY MARJAN J. SLOB, WILLEM JAN VAN ROOIJ AND MENNO SLUZEWSKI, PUBLISHED NEUROLOGICAL RESEARCH, 2005, VOLUME 27, 000 S1, THE DEVICES ARE NOT AVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER INFORMATION HAS BEEN REPORTED THUS, NO ANALYSIS OR DHR COULD BE PERFORMED. ANEURYSM RECANALIZATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CODMAN EMBOLIC OILS AND IS LISTED IN THE DEVICE IFUS AS SUCH. UNSPECIFIED PROCEDURAL COMPLICATIONS ARE NOT DESCRIBED IN THE IFU. 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 INFORMATION SUGGESTS THAT TARGET LESION ANATOMY, COIL DENSITY AND DISEASE PROCESS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT OF RECANALIZATION. IT IS NOT POSSIBLE TO MAKE A CONCLUSION REGARDING CONTRIBUTING FACTORS FOR THE UNSPECIFIED PROCEDURAL COMPLICATIONS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INFLUENCE OF COIL THICKNESS ON PACKING, RE-OPENING AND RETREATMENT OF INTRACRANIAL ANEURYSMS: A COMPARATIVE STUDY BETWEEN TWO TYPES OF COILS¿ BY MARJAN J. SLOB, WILLEM JAN VAN ROOIJ AND MENNO SLUZEWSKI, PUBLISHED NEUROLOGICAL RESEARCH, 2005, VOLUME 27, 000 S1, THE AUTHORS COMPARE PACKING, RE-OPENING AND RETREATMENT OF INTRACRANIAL ANEURYSMS TREATED WITH TWO TYPES OF COILS WITH DIFFERENT WIRE THICKNESS AND DIFFERENT SHAPES. TWO-HUNDRED THIRTY-FIVE (235) ANEURYSMS IN 217 PATIENTS WERE TREATED EITHER WITH GDC 10 COILS (0.010-INCH DIAMETER WIRE, REGULAR, SOFT AND ULTRA SOFT, 3D AND HELICAL, BOSTON SCIENTIFIC), OR CORDIS TRUFILL DCS OR ORBIT COILS (0.012-INCH DIAMETER WIRE, COMPLEX AND HELICAL, CORDIS). THE CHOICE BETWEEN GDC 10 COILS OR CORDIS TRUFILL COILS WAS INFLUENCED BY FACTORS SUCH AS OPERATOR PREFERENCE AND THE AVAILABILITY OF COILS IN STOCK, BUT WAS INDEPENDENT OF ANEURYSM OR PATIENT CHARACTERISTICS. OF 217 PATIENTS, 143 WERE WOMEN AND 74 WERE MEN, WITH A MEAN AGE OF 53 YEARS (MEDIAN 53, RANGE 19¿83 YEARS). OF 235 ANEURYSMS, 120 WERE TREATED WITH GDC 10 COILS AND 115 WITH CORDIS TRUFILL COILS. ANEURYSM PACKING, REOPENING AND RETREATMENT DURING FOLLOW-UP WERE COMPARED FOR ANEURYSMS TREATED WITH EITHER TYPE OF COILS. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN MEAN ANEURYSM VOLUME, PROPORTION OF RUPTURED ANEURYSMS AND ANEURYSM LOCATION IN ANEURYSMS TREATED WITH GDC 10 COILS VERSUS ANEURYSMS TREATED WITH CORDIS TRUFILL COILS. MEAN PACKING WAS SIGNIFICANTLY HIGHER IN ANEURYSMS COILED WITH CORDIS TRUFILL COILS THAN IN ANEURYSMS COILED WITH GDC 10 COILS. INSERTED COIL LENGTH PER MM^3 ANEURYSM WAS EQUAL FOR BOTH TYPES OF COILS. THE ANEURYSM VOLUME FILLED PER COIL WAS HIGHER FOR ANEURYSMS TREATED WITH CORDIS TRUFILL COILS. OF THE 217 PATIENTS TREATED WITH EITHER TYPE OF COIL, FOUR PATIENTS SUFFERED PROCEDURE-RELATED COMPLICATIONS LEADING TO DEATH OR DEPENDENCY. OF THESE FOUR PATIENTS, TWO WERE TREATED WITH GDC 10 COILS AND TWO WITH CORDIS TRUFILL COILS. OF 95 ANEURYSMS TREATED WITH CORDIS TRUFILL COILS, 15 (15.8%) WERE INCOMPLETELY OCCLUDED AT 6 MONTHS. OF THESE 15 ANEURYSMS, EIGHT WERE ADDITIONALLY COILED AND ONE WAS ADDITIONALLY CLIPPED. SIX OF 15 ANEURYSMS WERE LEFT UNTREATED SINCE ANEURYSM MORPHOLOGY PRECLUDED SAFE INSERTION OF ADDITIONAL COILS OR SAFE PLACEMENT OF A CLIP. 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
    395567 G2 TDL COMPLEX FILL COIL 5X10 NEUROVASCULAR EMBOLIZATION DEVICE KRD CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R| S