BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-THERMO MECHANICAL

    MDR report key: 7682417 · Received July 12, 2018

    Report

    Report Number
    3008114965-2018-00673
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    December 31, 2013
    Report Date
    June 21, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    PMA / PMN Number
    K053160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: LANG, S., RÖSCH, J., GÖLITZ, P., KLOSKA, S., STRUFFERT, T., AND DOERFLER, A. (2015). COMPARISON OF INTRACRANIAL ANEURYSMS TREATED BY 2-D VERSUS 3-D COILS: A MATCHED-PAIRS ANALYSIS. CLINICAL NEURORADIOLOGY, 27(1), 43-49. DOI:10.1007/S00062-015-0408-9. THE NUMBER OF COILS USED IN EACH PROCEDURE WAS NOT SPECIFIED IN THE ARTICLE. HOWEVER, SINCE IT IS KNOWN THAT MULTIPLE COILS ARE USED IN THE VAST MAJORITY OF PROCEDURES, CERENOVUS CAPTURED THE NUMBER OF DEVICES AS 2 FOR EACH PROCEDURE INVOLVING AN ADVERSE EVENT MENTIONED IN THE ARTICLE. THIS MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS (QUANTITY OF 6) WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. THIS MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS (QUANTITY OF 6) WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. THE MICRUSPHERE COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. DUE TO THE NATURE OF THE COMPLAINT, THE STERILE LOT NUMBERS WERE NOT PROVIDED IN ORDER TO CONDUCT LOT HISTORY REVIEWS. PROCODE: KRD/HCG. (B)(4). INITIAL REPORTER PHONE AND FAX WERE NOT REPORTED. (B)(4). COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED ¿COMPARISON OF INTRACRANIAL ANEURYSMS TREATED BY 2-D VERSUS 3-D COILS: A MATCHED-PAIRS ANALYSIS¿, THREE PATIENTS IN THE 3-D GROUP (MICRUSPHERE COILS), EXPERIENCED INTRAPROCEDURAL THROMBUS FORMATION AT THE NECK OF THE ANEURYSM THAT WAS SUCCESSFULLY TREATED BY ABCIXIMAB WITHOUT ANY CLINICAL SEQUELAE. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE WHETHER THE USE OF 3-D (MICRUSPHERE) VERSUS 2-D COILS (HELIPAQ) ALONE MAY IMPROVE THE EFFICACY OF ENDOVASCULAR ANEURYSM TREATMENT. IN THE RETROSPECTIVE ANALYSIS, PATIENTS TREATED BETWEEN 2005 AND 2013 WERE SCREENED TO PERFORM A MATCHED-PAIRS ANALYSIS. ANEURYSMS WERE INCLUDED IN THE 2-D GROUP IF THEY HAD BEEN TREATED BY 2-D COILS EXCLUSIVELY AND ANEURYSM WERE INCLUDED IN THE 3-D GROUP IF AT LEAST TWO 3-D COILS WERE USED AS INITIAL FRAMING COILS. SUBSEQUENT FILLING WAS PERFORMED BY 3-D OR 2-D COILS. PATIENTS TREATED WITH ASSISTING DEVICES LIKE STENTS, BALLOONS OR FLOW DIVERTERS WERE EXCLUDED. EXCLUSIVELY SACCULAR ANEURYSMS WERE REVIEWED. ACCORDING TO THE FOLLOW-UP PROTOCOL, 6 MONTHS AFTER TREATMENT, A COMBINATION OF MAGNETIC RESONANCE IMAGING (MRI) [TIME-OF-FLIGHT MAGNETIC RESONANCE ANGIOGRAPHY (TOF-MRA), CONTRAST-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY (CE-MRA)] AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE PERFORMED. 18 MONTHS AFTER TREATMENT, ONLY MRI WAS PERFORMED. ONLY PATIENTS WITH COMPLETE FOLLOW-UP FOR AT LEAST 18 MONTHS WERE TAKEN INTO CONSIDERATION. THERE WERE 38 FEMALES AND 10 MALES IN EACH GROUP WITH MEAN AGE OF 56 YEARS. IN ALL, 58% OF THE ANEURYSM PAIRS WERE RUPTURED AND 76% WERE LOCATED AT THE ANTERIOR CIRCULATION. SYSTEMIC HEPARINIZATION (5000 IE) WAS INITIATED PRIOR TO TREATMENT TO PREVENT THROMBOEMBOLIC EVENTS. THE PATIENTS WERE TREATED WITH ASPIRIN 100 MG FOR 6 WEEKS POST-TREATMENT. TO ASSESS THE PACKING DENSITY, TWO DIFFERENT PARAMETERS WERE EVALUATED. FIRST, THE RATIO OF THE COIL VOLUME TO THE ANEURYSMAL VOLUME WAS CALCULATED (PACKING DENSITY IN PERCENTAGE). SECOND, PACKING DENSITY OF COILED ANEURYSMS WAS DEFINED AS THE RELATION BETWEEN IMPLANTED COIL LENGTH IN MM TO ANEURYSMAL VOLUME IN MM3 (COIL LENGTH PER VOLUME). THE NUMBER OF COILS USED IN EACH CASE WAS REVIEWED AND THE TOTAL COIL LENGTH IMPLANTED WAS CALCULATED. IF SIGNIFICANT RECANALIZATION WAS DETECTED AT 6- OR 18-MONTH FOLLOW-UP, RETREATMENT WAS CONSIDERED. RETREATED ANEURYSMS WERE RE-EVALUATED 6 AND 18 MONTHS AFTER RECOILING ACCORDING TO THE FOLLOW-UP PROTOCOL BY DSA AND MRA. THERE WAS NO COIL DISLOCATION AFTER RELEASE OR ACUTE ANEURYSM RUPTURE DUE TO COIL PLACEMENT. NONE OF THE PATIENTS SUFFERED FROM SUBARACHNOID HEMORRHAGE OR ISCHEMIC EVENTS DURING THE 18-MONTH FOLLOW-UP PERIOD. RETREATMENT WAS NOT ASSOCIATED WITH PERIPROCEDURAL COMPLICATIONS. THE STUDY CONCLUDED THAT ANEURYSMS TREATED BY 3-D COILS EXHIBITED A MORE STABLE AND IMPROVED OCCLUSION THAN ANEURYSMS TREATED BY 2-D COILS DURING LONG-TERM FOLLOW-UP. INITIAL USE OF 3-D COILS REVEALED A SIGNIFICANTLY HIGHER PACKING DENSITY AS COMPARED WITH SINGLE USE OF 2-D COILS IN THE MATCHED-PAIRS ANALYSIS SUPPORTING THE IDEA THAT A HIGH PACKING DENSITY SUPPORTS A FAVORABLE LONG-TERM OCCLUSION. NO PATIENT, PROCEDURE, OR DEVICE-SPECIFIC INFORMATION (INCLUDING CATALOG AND LOT NUMBERS) WAS REPORTED IN THE ARTICLE. NO FURTHER INFORMATION WAS PROVIDED. THE MICRUSPHERE COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBERS ARE NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THERMO-MECHANICAL COILS AND COIL EMBOLIZATION PROCEDURES. ALTHOUGH BASED ON THE LIMITED AVAILABLE INFORMATION NO DEFINITIVE CONCLUSION OF ROOT CAUSE CAN BE MADE, IT IS POSSIBLE THAT PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS INCLUDING RESPONSIVENESS TO ANTIPLATELET THERAPY AND ANTICOAGULATION MAY HAVE CONTRIBUTED TO THE EVENTS. THERE MAY HAVE BEEN PRE-EXISTING THROMBUS WITHIN OR AROUND THE ANEURYSM OR NEW THROMBUS MAY HAVE FORMED ON THE COIL SURFACE. LASTLY, THROMBUS MAY FORM ON CATHETERS DURING THE PROCEDURE. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENTS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF FOUR PRODUCT EVENTS INVOLVED WITH THE LITERATURE PUBLICATION AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00672, THIS REPORT, 3008114965-2018-00674, AND 3008114965-2018-00675.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED ¿COMPARISON OF INTRACRANIAL ANEURYSMS TREATED BY 2-D VERSUS 3-D COILS: A MATCHED-PAIRS ANALYSIS¿, THREE PATIENTS IN THE 3-D GROUP (MICRUSPHERE COILS) EXPERIENCED INTRAPROCEDURAL THROMBUS FORMATION AT THE NECK OF THE ANEURYSM THAT WAS SUCCESSFULLY TREATED BY ABCIXIMAB WITHOUT ANY CLINICAL SEQUELAE. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE WHETHER THE USE OF 3-D (MICRUSPHERE) VERSUS 2-D COILS (HELIPAQ) ALONE MAY IMPROVE THE EFFICACY OF ENDOVASCULAR ANEURYSM TREATMENT. IN THE RETROSPECTIVE ANALYSIS, PATIENTS TREATED BETWEEN 2005 AND 2013 WERE SCREENED TO PERFORM A MATCHED-PAIRS ANALYSIS. ANEURYSMS WERE INCLUDED IN THE 2-D GROUP IF THEY HAD BEEN TREATED BY 2-D COILS EXCLUSIVELY AND ANEURYSM WERE INCLUDED IN THE 3-D GROUP IF AT LEAST TWO 3-D COILS WERE USED AS INITIAL FRAMING COILS. SUBSEQUENT FILLING WAS PERFORMED BY 3-D OR 2-D COILS. PATIENTS TREATED WITH ASSISTING DEVICES LIKE STENTS, BALLOONS OR FLOW DIVERTERS WERE EXCLUDED. EXCLUSIVELY SACCULAR ANEURYSMS WERE REVIEWED. ACCORDING TO THE FOLLOW-UP PROTOCOL, 6 MONTHS AFTER TREATMENT, A COMBINATION OF MAGNETIC RESONANCE IMAGING (MRI) [TIME-OF-FLIGHT MAGNETIC RESONANCE ANGIOGRAPHY (TOF-MRA), CONTRAST-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY (CE-MRA)] AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE PERFORMED. EIGHTEEN (18) MONTHS AFTER TREATMENT, ONLY MRI WAS PERFORMED. ONLY PATIENTS WITH COMPLETE FOLLOW-UP FOR AT LEAST 18 MONTHS WERE TAKEN INTO CONSIDERATION. THERE WERE 38 FEMALES AND 10 MALES IN EACH GROUP WITH MEAN AGE OF 56 YEARS. IN ALL, 58% OF THE ANEURYSM PAIRS WERE RUPTURED AND 76% WERE LOCATED AT THE ANTERIOR CIRCULATION. SYSTEMIC HEPARINIZATION (5000 IE) WAS INITIATED PRIOR TO TREATMENT TO PREVENT THROMBOEMBOLIC EVENTS. THE PATIENTS WERE TREATED WITH ASPIRIN 100 MG FOR 6 WEEKS POST-TREATMENT. TO ASSESS THE PACKING DENSITY, TWO DIFFERENT PARAMETERS WERE EVALUATED. FIRST, THE RATIO OF THE COIL VOLUME TO THE ANEURYSMAL VOLUME WAS CALCULATED (PACKING DENSITY IN PERCENTAGE). SECOND, PACKING DENSITY OF COILED ANEURYSMS WAS DEFINED AS THE RELATION BETWEEN IMPLANTED COIL LENGTH IN MM TO ANEURYSMAL VOLUME IN MM3 (COIL LENGTH PER VOLUME). THE NUMBER OF COILS USED IN EACH CASE WAS REVIEWED AND THE TOTAL COIL LENGTH IMPLANTED WAS CALCULATED. IF SIGNIFICANT RECANALIZATION WAS DETECTED AT 6- OR 18-MONTH FOLLOW-UP, RETREATMENT WAS CONSIDERED. RETREATED ANEURYSMS WERE RE-EVALUATED 6 AND 18 MONTHS AFTER RECOILING ACCORDING TO THE FOLLOW-UP PROTOCOL BY DSA AND MRA. THERE WAS NO COIL DISLOCATION AFTER RELEASE OR ACUTE ANEURYSM RUPTURE DUE TO COIL PLACEMENT. NONE OF THE PATIENTS SUFFERED FROM SUBARACHNOID HEMORRHAGE OR ISCHEMIC EVENTS DURING THE 18-MONTH FOLLOW-UP PERIOD. RETREATMENT WAS NOT ASSOCIATED WITH PERIPROCEDURAL COMPLICATIONS. THE STUDY CONCLUDED THAT ANEURYSMS TREATED BY 3-D COILS EXHIBITED A MORE STABLE AND IMPROVED OCCLUSION THAN ANEURYSMS TREATED BY 2-D COILS DURING LONG-TERM FOLLOW-UP. INITIAL USE OF 3-D COILS REVEALED A SIGNIFICANTLY HIGHER PACKING DENSITY AS COMPARED WITH SINGLE USE OF 2-D COILS IN THE MATCHED-PAIRS ANALYSIS SUPPORTING THE IDEA THAT A HIGH PACKING DENSITY SUPPORTS A FAVORABLE LONG-TERM OCCLUSION. NO PATIENT, PROCEDURE, OR DEVICE-SPECIFIC INFORMATION (INCLUDING CATALOG AND LOT NUMBERS) WAS REPORTED IN THE ARTICLE. THE COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522905 COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R