BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 6661864 · Received June 22, 2017

    Report

    Report Number
    3008264254-2017-00093
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    March 15, 2006
    Report Date
    May 29, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K123560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    YAN, B., ROCHEMENT, R., RAABE, A. ET AL. (2006). SINGLE-CENTER EXPERIENCE WITH TRUFILL PLATINUM COILS FOR THE EMBOLIZATION OF CEREBRAL ANEURYSMS. NEURORADIOLOGY (2006) 48: 264¿268 DOI 10.1007/S00234-005-0029-0. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: 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. COIL STRETCHING IS A KNOWN PROCEDURAL COMPLICATION RELATED TO COIL EMBOLIZATION PROCEDURES, AND COULD BE RELATED TO PROCEDURAL ANEURYSM FACTORS. HEMORRHAGE IS ALSO A KNOWN COMPLICATION WITH COIL EMBOLIZATION AND COULD BE RELATED TO THE HISTORY OF PREVIOUS SUBARACHNOID HEMORRHAGE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT. THIS IS 1 OF 3 MDR REPORTS SUBMITTED FOR THIS LITERATURE ARTICLE WITH ASSOCIATED REPORT NUMBERS OF 3008264254-2017-00093, 3008264254-2017-00094 AND 3008264254-2017-00095.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿SINGLE-CENTER EXPERIENCE WITH TRUFILL PLATINUM COILS FOR THE EMBOLIZATION OF CEREBRAL ANEURYSMS¿ BY BERNARD YAN, RICHARD DU MESNIL DE ROCHEMENT, ANDREAS RAABE, FRIEDHELM ZANELLA, JOACHIM BERKEFELD, PUBLISHED NEURORADIOLOGY (2006) 48: 264¿268 DOI 10.1007/S00234-005-0029-0, THE AUTHORS REPORT THEIR INITIAL CLINICAL EXPERIENCE WITH THE EMBOLIZATION OF ANEURYSMS BY TRUFILL COILS. AS REPORTED IN THE ARTICLE, 3 PATIENTS EXPERIENCED RECANALIZATION, 2 PATIENTS EXPERIENCED COIL STRETCHING, AND 2 PATIENTS EXPIRED DUE TO RECURRENT SUBARACHNOID HEMORRHAGE AFTER IMPLANTATION OF TRUFILL COILS (CATALOG AND LOT NUMBERS UNSPECIFIED). FROM MAY 2002 TO NOVEMBER 2003, 26 PATIENTS (9 MALE, 17 FEMALE; MEAN AGE 55.4 YEARS) WITH 28 ANEURYSMS (38 RUPTURED AND 7 UNRUPTURED) WERE TREATED EXCLUSIVELY BY ENDOVASCULAR EMBOLIZATION WITH TRUFILL PLATINUM COILS. OF THE 28 ANEURYSMS, 16 (57%) WERE COMPLETELY OCCLUDED BY TRUFILL EMBOLIZATION, 11 (39%) WERE INCOMPLETELY OCCLUDED WITH RESIDUAL NECKS, AND 1 (4%) WAS PARTIALLY OCCLUDED AS RESIDUAL ANEURYSM. THERE WERE NO ANEURYSMAL RUPTURES DURING THE PROCEDURES. FOLLOW-UP AT 6 MONTHS AFTER THE PROCEDURE WAS AVAILABLE IN 18 PATIENTS AND 19 ANEURYSMS. THERE WERE TWO DEATHS (8%) FROM DELAYED RECURRENT SUBARACHNOID HEMORRHAGE IN PATIENTS WITH INCOMPLETELY COILED LARGE ANEURYSMS. ONE ANEURYSM WAS 15 MM WITH A 10-MM NECK (RESIDUAL ANEURYSM) AND THE OTHER WAS 10 MM WITH A 7-MM NECK (RESIDUAL NECK). THERE WERE TWO INCIDENTS OF COILS BEING STRETCHED. BOTH CASES OCCURRED DURING DEPLOYMENT OF THE LAST AND THE SECOND TO LAST COIL, RESPECTIVELY, PRIOR TO COMPLETION OF THE TWO PROCEDURES. BOTH ¿STRETCHED¿ COILS WERE RETRIEVED BY THE GOOSENECK SNARE DEVICE WITHOUT FURTHER EVENTS¿NEITHER THROMBOEMBOLIC COMPLICATIONS NOR INADVERTENT COIL PACKAGE REMOVAL. THREE PATIENTS SHOWED RECANALIZATION AT THE 6 MONTH FOLLOW-UP. A PATIENT WITH A RECANALIZED ANEURYSM (RESIDUAL ANEURYSM) WHICH WAS SUBSEQUENTLY RECOILED WITH CONSEQUENT RESIDUAL NECK AND REMAINED UNCHANGED AT THE 1-YEAR FOLLOW-UP. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440448 UNK UNK HCG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1