BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN CERECYTE MICROCOIL

    MDR report key: 6630264 · Received June 9, 2017

    Report

    Report Number
    2954740-2017-00124
    Event Type
    Death
    Date Received
    June 9, 2017
    Date of Event
    May 16, 2008
    Report Date
    May 18, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: KRD/HCG. THIS MDR IS TO REPORT THE 1 CASES OF ANEURYSM RUPTURE THAT RESULTED IN DEATH. UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. THERE WAS NO PATIENT, DEVICE, OR PROCEDURE RELATED INFORMATION PROVIDED IN THE LITERATURE ARTICLE, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE AUTHOR AFTER 3 ATTEMPTS TO OBTAIN INFORMATION. THIS ARTICLE WAS ATTACHED TO THIS MDR REPORT: GEYIK, S. YAVUS, K., ERGUN, O., ET AL. (2008). ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS WITH BIOACTIVE CERECYTE COILS: EFFECTS ON TREATMENT STABILITY. NEURORADIOLOGY (2008) 50:787¿793 ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS 1 OF 4 MDR REPORTS SUBMITTED FOR THIS LITERATURE ARTICLE, WITH ASSOCIATED REPORT NUMBERS OF 2954740-2017-00126, 2954740-2017-00125, 2954740-2017-00123.

    Additional Manufacturer Narrative · 1

    CONCLUSION: IN THE LITERATURE ARTICLE ¿ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS WITH BIOACTIVE CERECYTE COILS: EFFECTS ON TREATMENT STABILITY¿ BY SERDAR GEYIK, KIVILCIM YAVUZ, ONUR ERGUN, ET AL, PUBLISHED NEURORADIOLOGY (2008) 50:787¿793, THE AUTHORS REPORT THEIR CLINICAL EXPERIENCE FOR ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS USING CERECYTE COILS. AFTER IMPLANTATION OF CERECYTE COILS (CATALOG/LOT UNREPORTED), IT WAS REPORTED THAT THERE WERE 4 ANEURYSM RUPTURES (3 WITHOUT CLINICAL CONSEQUENCES AND 1 RESULTING IN DEATH), 5 OCCLUSIVE CLOT FORMATIONS (3 WITHOUT CLINICAL CONSEQUENCE, 2 WITH NEUROLOGICAL DEFICITS) AND 9 RECANALIZATIONS. THE STUDY AIMED TO EVALUATE THE EFFECTS OF THE BIOACTIVE CERECYTE COILS REGARDING THE DURABILITY OF ENDOVASCULAR COILING AND THE EFFICACY OF PREVENTING RECANALIZATION. SEVENTY-EIGHT CONSECUTIVE PATIENTS WITH 84 INTRACRANIAL ANEURYSMS TREATED EXCLUSIVELY WITH CERECYTE COILS WERE INCLUDED IN THIS STUDY. THE PATIENT POPULATION CONSISTED OF 43 FEMALES AND 35 MALES (AGED 30 TO 64 WITH A MEAN AGE OF 58.3 YEARS). FORTY-EIGHT ANEURYSMS WERE RUPTURED AND 36 WERE INCIDENTAL. TWENTY-TWO ANEURYSMS WERE SMALL WITH (<10 MM) SMALL NECK (<4 MM) (SASN); 55 WERE SMALL WITH WIDE NECK (=4 MM) (SAWN); SIX WERE LARGE (10¿25 MM) (L); AND ONE WAS GIANT (G) (>25MM) WHICH HAD PARTIAL THROMBOSIS. THE EMBOLIZATION TECHNIQUE WAS THE SAME WITH THAT IN STANDARD BARE COILING. ALL ANEURYSMS IN THIS SERIES WERE COILED EXCLUSIVELY WITH CERECYTE COILS. ANTICOAGULATION PROTOCOL CONSISTED OF INTRAVENOUS ADMINISTRATION OF HEPARIN WITH CLOSE MONITORING WITH MAINTAINING ACT 2 TO 3 TIMES THE BASAL LEVEL DURING THE PROCEDURE. HEPARIN WAS CONTINUED AFTER THE PROCEDURE UNTIL THE NEXT DAY IF THE ANEURYSM HAD A LARGE NECK. ALL ANEURYSM EXCEPT THREE WERE TREATED WITH BALLOON ASSISTANCE. ANEURYSMS WERE PACKED AS DENSELY AS POSSIBLE UNTIL ANGIOGRAPHICALLY COMPLETE OCCLUSION WAS ACHIEVED AND/OR THE LAST COIL COULD NOT BE INTRODUCED INTO THE SAC. THERE WAS INTRAOPERATIVE ANEURYSM RUPTURE DURING COILING IN FOUR ANEURYSMS (4/84), BUT IT WAS WITHOUT CLINICAL CONSEQUENCE IN THREE OF THEM (SYMPTOMATIC INTRAOPERATIVE ANEURYSM RUPTURE), AS EXTRAVASATION WAS MINIMAL DUE TO RAPID BALLOON INFLATION AT THE ANEURYSM NECK WHILE CONTINUING FURTHER COIL PACKING ACCOMPANIED WITH PROTAMINE INJECTION. IN THE REMAINING PATIENT, THE COMPLICATION LED TO DEATH, WHICH WAS THE ONLY PROCEDURE-RELATED MORTALITY IN THIS SERIES. OCCLUSIVE CLOT FORMATION WAS OBSERVED DURING OR IMMEDIATELY AFTER THE PROCEDURE IN FIVE ANEURYSMS (6%), AND ALL WERE TREATED WITH INTRAVENOUS AND/OR LOCAL INJECTION OF TIROFIBAN. OF THESE, THROMBOEMBOLIC OCCLUSION WAS RESOLVED TOTALLY WITHOUT PRODUCING ANY CLINICAL CONSEQUENCE IN THREE PATIENTS. THE REMAINING TWO PATIENTS COMPRISED THE PROCEDURAL MORBIDITY (2/78) OF THIS SERIES, ONE HAVING DISABLING NEUROLOGIC DEFICIT (MRS 3) AND THE OTHER BEING INDEPENDENT AT SIXTH MONTH AFTER INITIAL TREATMENT (MRS 1). IN THE 80 ANEURYSMS, AVAILABLE FOR FOLLOW-UP, NINE ANEURYSMS SHOWED RECANALIZATION IN THE FOLLOW-UP WITH AN OVERALL RECANALIZATION RATE OF 11.3%, AND FIVE ANEURYSMS WERE RETREATED, RESULTING IN A RE-TREATMENT RATE OF 6.3%. OF THE 57 ANEURYSMS THAT SHOWED CLASS I OBLITERATION AT THE INITIAL ANGIOGRAPHY, FOLLOW-UP ANGIOGRAPHY DEMONSTRATED RECANALIZATION WITH A RESULTANT RAYMOND CLASS II IN FOUR PATIENTS AND RAYMOND CLASS III IN ONE PATIENT (1.8%). OF THE 22 ANEURYSMS THAT SHOWED CLASS II OBLITERATION AT INITIAL ANGIOGRAPHY, THREE (13.6%) SHOWED RECANALIZATION WITH A RESULTANT CLASS III AND TWO (9.1%) STAYED UNCHANGED WITH RAYMOND CLASS II, AND THE REMAINING 17 ANEURYSMS SHOWED FURTHER THROMBOSIS (FIG. 2). THE ONLY PATIENT WHO HAD CLASS III OCCLUSION AT THE END OF THE TREATMENT SHOWED INCREASED ANEURYSM FILLING IN THE FOLLOW-UP. ALL FIVE ANEURYSMS WITH CLASS III OCCLUSION IN THE FOLLOW-UP WERE RE-TREATED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR; HOWEVER, THERE WAS NO DEVICE SPECIFIC INFORMATION (I.E. CATALOG/LOT NUMBER) AVAILABLE, AND NO PATIENT SPECIFIC INFORMATION PROVIDED. THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, NO LOT NUMBERS COULD BE OBTAINED; THEREFORE, A DHR COULD NOT BE PERFORMED FOR THE DEVICES. RECANALIZATION IS A KNOWN POTENTIAL PRODUCT MALFUNCTION ASSOCIATED WITH THE USE OF THE CODMAN EMBOLIC COIL DEVICES AND THE IFU WARNS THAT MULTIPLE PROCEDURES MAY BE NEEDED FOR COMPLETE OBLITERATION OF THE TARGET LESION. ANEURYSM RUPTURE IS ALSO A KNOWN PROCEDURAL POTENTIAL EVENT. THESE PROCEDURES INVOLVE TREATMENT OF ANEURYSMS WHICH HAVE KNOWN VESSEL WALL WEAKNESS AND USE MULTIPLE PRODUCTS IN COMBINATIONS. PROCEDURAL FACTORS INCLUDING VESSEL/ANEURYSM CHARACTERISTICS, DEVICE MANIPULATION AND INTERACTION ARE POSSIBLE CONTRIBUTING FACTORS TO THE ANEURYSM RUPTURE. EMBOLIC COMPLICATIONS ARE A KNOWN RISK ASSOCIATED WITH COILING PROCEDURES, AS IDENTIFIED IN THE PRODUCT IFU. THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 4 FINAL MDR REPORTS SUBMITTED FOR THIS LITERATURE ARTICLE, WITH ASSOCIATED REPORT NUMBERS OF 2954740-2017-00126, 2954740-2017-00125, 2954740-2017-00124 AND 2954740-2017-00123.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS WITH BIOACTIVE CERECYTE COILS: EFFECTS ON TREATMENT STABILITY¿ BY SERDAR GEYIK, KIVILCIM YAVUZ, ONUR ERGUN, ET AL, PUBLISHED NEURORADIOLOGY (2008) 50:787¿793, THE AUTHORS REPORT THEIR CLINICAL EXPERIENCE FOR ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS USING CERECYTE COILS. AFTER IMPLANTATION OF CERECYTE COILS (CATALOG/LOT UNREPORTED), IT WAS REPORTED THAT THERE WERE 4 ANEURYSM RUPTURES (3 WITHOUT CLINICAL CONSEQUENCES AND 1 RESULTING IN DEATH), 5 OCCLUSIVE CLOT FORMATIONS (3 WITHOUT CLINICAL CONSEQUENCE, 2 WITH NEUROLOGICAL DEFICITS) AND 9 RECANALIZATIONS. THE STUDY AIMED TO EVALUATE THE EFFECTS OF THE BIOACTIVE CERECYTE COILS REGARDING THE DURABILITY OF ENDOVASCULAR COILING AND THE EFFICACY OF PREVENTING RECANALIZATION. SEVENTY-EIGHT CONSECUTIVE PATIENTS WITH 84 INTRACRANIAL ANEURYSMS TREATED EXCLUSIVELY WITH CERECYTE COILS WERE INCLUDED IN THIS STUDY. THE PATIENT POPULATION CONSISTED OF 43 FEMALES AND 35 MALES (AGED 30 TO 64 WITH A MEAN AGE OF 58.3 YEARS). FORTY-EIGHT ANEURYSMS WERE RUPTURED AND 36 WERE INCIDENTAL. TWENTY TWO ANEURYSMS WERE SMALL WITH (<10 MM) SMALL NECK (<4 MM) (SASN); 55 WERE SMALL WITH WIDE NECK (=4 MM) (SAWN); SIX WERE LARGE (10¿25 MM) (L); AND ONE WAS GIANT (G) (>25MM) WHICH HAD PARTIAL THROMBOSIS. THE EMBOLIZATION TECHNIQUE WAS THE SAME WITH THAT IN STANDARD BARE COILING. ALL ANEURYSMS IN THIS SERIES WERE COILED EXCLUSIVELY WITH CERECYTE COILS. ANTICOAGULATION PROTOCOL CONSISTED OF INTRAVENOUS ADMINISTRATION OF HEPARIN WITH CLOSE MONITORING WITH MAINTAINING ACT 2 TO 3 TIMES THE BASAL LEVEL DURING THE PROCEDURE. HEPARIN WAS CONTINUED AFTER THE PROCEDURE UNTIL THE NEXT DAY IF THE ANEURYSM HAD A LARGE NECK. ALL ANEURYSM EXCEPT THREE WERE TREATED WITH BALLOON ASSISTANCE. ANEURYSMS WERE PACKED AS DENSELY AS POSSIBLE UNTIL ANGIOGRAPHICALLY COMPLETE OCCLUSION WAS ACHIEVED AND/OR THE LAST COIL COULD NOT BE INTRODUCED INTO THE SAC. THERE WAS INTRAOPERATIVE ANEURYSM RUPTURE DURING COILING IN FOUR ANEURYSMS (4/84), BUT IT WAS WITHOUT CLINICAL CONSEQUENCE IN THREE OF THEM (SYMPTOMATIC INTRAOPERATIVE ANEURYSM RUPTURE), AS EXTRAVASATION WAS MINIMAL DUE TO RAPID BALLOON INFLATION AT THE ANEURYSM NECK WHILE CONTINUING FURTHER COIL PACKING ACCOMPANIED WITH PROTAMINE INJECTION. IN THE REMAINING PATIENT, THE COMPLICATION LED TO DEATH, WHICH WAS THE ONLY PROCEDURE-RELATED MORTALITY IN THIS SERIES. OCCLUSIVE CLOT FORMATION WAS OBSERVED DURING OR IMMEDIATELY AFTER THE PROCEDURE IN FIVE ANEURYSMS (6%), AND ALL WERE TREATED WITH INTRAVENOUS AND/OR LOCAL INJECTION OF TIROFIBAN. OF THESE, THROMBOEMBOLIC OCCLUSION WAS RESOLVED TOTALLY WITHOUT PRODUCING ANY CLINICAL CONSEQUENCE IN THREE PATIENTS. THE REMAINING TWO PATIENTS COMPRISED THE PROCEDURAL MORBIDITY (2/78) OF THIS SERIES, ONE HAVING DISABLING NEUROLOGIC DEFICIT (MRS 3) AND THE OTHER BEING INDEPENDENT AT SIXTH MONTH AFTER INITIAL TREATMENT (MRS 1). IN THE 80 ANEURYSMS AVAILABLE FOR FOLLOW-UP, NINE ANEURYSMS SHOWED RECANALIZATION IN THE FOLLOW-UP WITH AN OVERALL RECANALIZATION RATE OF 11.3%, AND FIVE ANEURYSMS WERE RETREATED, RESULTING IN A RE-TREATMENT RATE OF 6.3%. OF THE 57 ANEURYSMS THAT SHOWED CLASS I OBLITERATION AT THE INITIAL ANGIOGRAPHY, FOLLOW-UP ANGIOGRAPHY DEMONSTRATED RECANALIZATION WITH A RESULTANT RAYMOND CLASS II IN FOUR PATIENTS AND RAYMOND CLASS III IN ONE PATIENT (1.8%). OF THE 22 ANEURYSMS THAT SHOWED CLASS II OBLITERATION AT INITIAL ANGIOGRAPHY, THREE (13.6%) SHOWED RECANALIZATION WITH A RESULTANT CLASS III AND TWO (9.1%) STAYED UNCHANGED WITH RAYMOND CLASS II, AND THE REMAINING 17 ANEURYSM SHOWED FURTHER THROMBOSIS (FIG. 2). THE ONLY PATIENT WHO HAD CLASS III OCCLUSION AT THE END OF THE TREATMENT SHOWED INCREASED ANEURYSM FILLING IN THE FOLLOW-UP. ALL FIVE ANEURYSMS WITH CLASS III OCCLUSION IN THE FOLLOW-UP WERE RE-TREATED. THERE WAS NO DEVICE SPECIFIC INFORMATION (I.E. CATALOG/LOT NUMBER) AVAILABLE, AND NO PATIENT SPECIFIC INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412537 UNKNOWN CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death