BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSFRAME10 5MM X 9.7CM

    MDR report key: 11719563 · Received April 23, 2021

    Report

    Report Number
    3008114965-2021-00143
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077848
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). THE PATIENT'S DATE OF BIRTH IS NOT AVAILABLE / REPORTED. PROCODE IS KRD/HCG. THE PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. [CONCLUSION]: THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD), MYOCARDIAL INFARCTION, AND SMOKING (PREVIOUS) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON (B)(6) 2021. THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 7MM, DOME 4.5MM, MAXIMUM ANEURYSM DIAMETER 5.5MM, NECK SIZE 4MM, AND DOME-TO-NECK RATIO 1.1MM. THE PARENT VESSEL DIAMETER WAS 4MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE 5MM X 9.7CM MICRUSFRAME10 COIL (MFR100509 / K10306), THREE 1.5MM X 4CM DELTAFILL10 (L11514, L10334, & L11298), TWO 2MM X 8CM DELTAFILL10 (K10471 & L17092), AND ONE 3MM X 8CM DELTAFILL10 (L16549) VIA AN EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER). A SINGLE LOOP OF THE 5MM X 9.7CM MICRUSFRAME10 COIL MINIMALLY PROLAPSED INTO THE PARENT VESSEL DURING THE PROCEDURE. THE COIL WAS REPORTEDLY DETACHED IN A GOOD POSITION, BUT THE PROLAPSE STARTED AFTER FILLING THE ANEURYSM WITH THE THIRD COIL AND PROCEEDED GRADUALLY UNTIL THE SEVENTH AND LAST COIL. THE PHYSICIAN ATTEMPTED TO CORRECT THE COIL POSITION WITH A 4MM X 10MM SCEPTER BALLOON CATHETER (MICROVENTION). THE PROLAPSE WAS CONSIDERED MINOR, IT DID NOT REQUIRE ANY STENT PLACEMENT. CLOPIDOGREL 75 MG/DAY, WHICH HAD ALREADY BEEN ADMINISTERED PRIOR TO THE PROCEDURE WILL BE CONTINUED FOR AT LEAST THREE MONTHS. NO ADDITIONAL PROCEDURE IS PLANNED. THERE WAS NO EVIDENCE OF FLOW RESTRICTION / REDUCTION, SUCH AS THROMBUS FORMATION, ASSOCIATED WITH THE EVENT. THE PHYSICIAN FURTHER REPORTED DIFFICULTY GETTING THIS COIL TO CONFORM TO THE ANEURYSM WALL DURING THE FIRST POSITIONING ATTEMPT; HOWEVER, THE PHYSICIAN WAS ULTIMATELY ABLE TO PLACE THE COIL DURING THE SECOND ATTEMPT. THE CASE REPORT FORM (CRF) INDICATES THAT THERE WERE TWO INSTANCES OF MICROCATHETER KICKBACK. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MICROCATHETER KICKBACK DURING THE USE OF THE TWO 1.5MM X 4CM DELTAFILL10 COILS (L11514 & L10334). HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 34% ANGIOSUITE PACKING DENSITY. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. THE REASON ADDITIONAL COILS WERE NOT PLACED WAS DUE TO THE MINOR PROLAPSE OF THE FRAMING COIL INTO PARENT VESSEL AND CONTRAST STASIS WITHIN THE ANEURYSM. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. THREE OF THE SEVEN CERENOVUS COILS WERE EXPIRED AT THE TIME OF IMPLANTATION. ADDITIONAL FOLLOW-UP REVEALED THAT THE SITE DID NOT CHECK THE EXPIRATION DATE OF THE COILS PRIOR TO IMPLANTATION. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10306) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. COIL POSITIONING DIFFICULTY (I.E., POOR CONFORMABILITY) AND PROTRUSION INTO PARENT VESSEL REQUIRING ADDITIONAL INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES. THE SPECTRA COIL INSTRUCTIONS FOR USE (IFU) STATES THAT MICROCOIL SELECTION IS AT THE DISCRETION OF THE PHYSICIAN. THE APPROPRIATE MICROCOIL SIZE SHOULD BE CHOSEN BASED UPON PRE-EMBOLIZATION ANGIOGRAPHIC ASSESSMENT OF THE DIAMETER, HEIGHT, AND WIDTH OF THE ANEURYSM, AS WELL AS THE WIDTH OF THE ANEURYSM OSTIUM (NECK). IN MOST CASES, THE INITIAL MICROCOIL IMPLANTED SHOULD BE A THREE-DIMENSIONAL SPHERICAL OR COMPLEX SHAPE. SUBSEQUENT IMPLANTED MICROCOILS MAY EITHER BE SPHERICAL, COMPLEX, OR HELICAL IN SHAPE. THE SELECTED COILS TYPICALLY WILL BE OF DECREASING SIZE AND THE PHYSICIAN MAY CONTINUE TO IMPLANT MICROCOILS UNTIL HE OR SHE DETERMINES THAT THE ANEURYSM HAS BEEN SUCCESSFULLY TREATED. WIDE-NECK (I.E., ¿ 4MM) ANEURYSMS ARE DIFFICULT TO TREAT AND ARE PRONE TO COIL PROTRUSION INTO THE PARENT VESSEL. WITH THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS (I.E., WIDE NECK), DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. SINCE THE ALLEGED PROTRUSION INTO PARENT VESSEL NECESSITATED ADDITIONAL INTERVENTION (I.E., USE OF THE SCEPTER BALLOON) IN AN ATTEMPT TO CORRECT THE COIL HERNIATION AND PRECLUDE PATIENT COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA WITH THE CLASSIFICATION OF ¿SERIOUS INJURY.¿ 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 EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD), MYOCARDIAL INFARCTION, AND SMOKING (PREVIOUS) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON (B)(6) 2021. THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 7MM, DOME 4.5MM, MAXIMUM ANEURYSM DIAMETER 5.5MM, NECK SIZE 4MM, AND DOME-TO-NECK RATIO 1.1MM. THE PARENT VESSEL DIAMETER WAS 4MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE 5MM X 9.7CM MICRUSFRAME10 COIL (MFR100509 / K10306), THREE 1.5MM X 4CM DELTAFILL10 (L11514, L10334, & L11298), TWO 2MM X 8CM DELTAFILL10 (K10471 & L17092), AND ONE 3MM X 8CM DELTAFILL10 (L16549) VIA AN EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER). A SINGLE LOOP OF THE 5MM X 9.7CM MICRUSFRAME10 COIL MINIMALLY PROLAPSED INTO THE PARENT VESSEL DURING THE PROCEDURE. THE COIL WAS REPORTEDLY DETACHED IN A GOOD POSITION, BUT THE PROLAPSE STARTED AFTER FILLING THE ANEURYSM WITH THE THIRD COIL AND PROCEEDED GRADUALLY UNTIL THE SEVENTH AND LAST COIL. THE PHYSICIAN ATTEMPTED TO CORRECT THE COIL POSITION WITH A 4MM X 10MM SCEPTER BALLOON CATHETER (MICROVENTION). THE PROLAPSE WAS CONSIDERED MINOR, IT DID NOT REQUIRE ANY STENT PLACEMENT. CLOPIDOGREL 75 MG/DAY, WHICH HAD ALREADY BEEN ADMINISTERED PRIOR TO THE PROCEDURE WILL BE CONTINUED FOR AT LEAST THREE MONTHS. NO ADDITIONAL PROCEDURE IS PLANNED. THERE WAS NO EVIDENCE OF FLOW RESTRICTION / REDUCTION, SUCH AS THROMBUS FORMATION, ASSOCIATED WITH THE EVENT. THE PHYSICIAN FURTHER REPORTED DIFFICULTY GETTING THIS COIL TO CONFORM TO THE ANEURYSM WALL DURING THE FIRST POSITIONING ATTEMPT; HOWEVER, THE PHYSICIAN WAS ULTIMATELY ABLE TO PLACE THE COIL DURING THE SECOND ATTEMPT. THE CASE REPORT FORM (CRF) INDICATES THAT THERE WERE TWO INSTANCES OF MICROCATHETER KICKBACK. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MICROCATHETER KICKBACK DURING THE USE OF THE TWO 1.5MM X 4CM DELTAFILL10 COILS (L11514 & L10334). HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 34% ANGIOSUITE PACKING DENSITY. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. THE REASON ADDITIONAL COILS WERE NOT PLACED WAS DUE TO THE MINOR PROLAPSE OF THE FRAMING COIL INTO PARENT VESSEL AND CONTRAST STASIS WITHIN THE ANEURYSM. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE (B)(6) 2021 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. THREE OF THE SEVEN CERENOVUS COILS WERE EXPIRED AT THE TIME OF IMPLANTATION. ADDITIONAL FOLLOW-UP REVEALED THAT THE SITE DID NOT CHECK THE EXPIRATION DATE OF THE COILS PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609184 MICRUSFRAME10 5MM X 9.7CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL MFR100509 L10306 10886704077848

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention