BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSFRAME10 3.5MM X 6.6CM

    MDR report key: 8469811 · Received April 1, 2019

    Report

    Report Number
    3008114965-2019-00950
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 5, 2019
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704077794
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO:(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE ADDITIONAL INFORMATION RECEIVED. THE SOURCE DOCUMENTATION WAS PROVIDED BY THE CLINICAL STUDY TEAM ON 09 JUNE 2021. [ADDITIONAL INFORMATION]: ON 09 JUNE 2021, THE CLINICAL STUDY TEAM PROVIDED SOURCE INFORMATION. THE INFORMATION WAS REVIEWED. THE 51-YEAR-OLD MALE PRESENTED WITH A HISTORY OF THUNDERCLAP HEADACHE AND SUBARACHNOID HEMORRHAGE SECONDARY TO RUPTURED LARGER ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND SMALLER LOBULATED RIGHT MCA TRIFURCATION ANEURYSM. HUNT AND HESS SCORE WAS 2 AND MODIFIED FISHER SCALE SCORE WAS 2. THE PATIENT UNDERWENT COIL EMBOLIZATION OF THE RUPTURED ACOM ANEURYSM AND EXTERNAL VENTRICULAR DRAIN (EVD) PLACEMENT ON (B)(6) 2019. THE STUDY PROCEDURE THAT OCCURRED ON (B)(6) 2019 WAS BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT MULTILOBULATED IRREGULAR WIDE-NECKED UNRUPTURED MCA ANEURYSM. 10MG OF NICARDIPINE WAS INFUSED TO REDUCE THE LIKELIHOOD OF VASOSPASM. FOLLOWING ANGIOGRAPHIC EVALUATION AND AFTER OBTAINING A WORKING PROJECTION, ANEURYSM EMBOLIZATION WAS THEN INITIATED BY COAXIALLY INTRODUCING AN SL-10 MICROCATHETER THROUGH THE 0.070¿ NEURON OVER AN 0.014¿ ASAHI MICROWIRE UNDER FLUOROSCOPIC AND ROAD MAP GUIDANCE INTO THE ANEURYSM LUMEN. MULTIPLE GALAXY COILS WERE THEN PLACED SEQUENTIALLY: ONE MICRUSFRAME10 (3.5 MM X 6.6CM), TWO GALAXY G3 MINI (2MM X 4CM), ONE 2MM X 6CM GALAXY G3 MINI, AND TWO 1.5MM X 3CM GALAXY G3 MINI. A 3MM X 6CM GALAXY G3 MINI COIL WAS NOT DEPLOYED. COIL OCCLUSION OF THIS ANEURYSM WAS SUPPORTED BY USING A BALLOON REMODELING TECHNIQUE, EMPLOYING AN EXTRA COMPLIANT 4MM X 11MM SCEPTER BALLOON, ALSO CO-AXIALLY INTRODUCED THROUGH THE 6F NEURON OVER AN 0.014 MICROWIRE, AND INTERMITTENTLY INFLATED ACROSS THE ANEURYSM NECK TO MAINTAIN THE PATENCY OF THE PARENT VESSEL, AND TO SECURELY POSITION THE COILS WITHIN THE ANEURYSM FUNDUS. THE INTERMITTENT AND PRE-AND POST-FINAL COIL PLACEMENT CEREBRAL ANGIOGRAM DEMONSTRATED PROGRESSIVE OCCLUSION OF THE CEREBRAL ANEURYSM (RAYMOND-ROY OCCLUSION SCORE I); HOWEVER, THERE WAS EVIDENCE OF SMALL COIL HERNIATION INTO THE ORIGIN OF THE SUPERIOR M2 MCA RESULTING INTO PARTIALLY OCCLUSIVE THROMBUS. BALLOON ANGIOPLASTY OF THE SUPERIOR M2 MCA ORIGIN ACROSS THE THROMBUS RESULTED IN DISTAL EMBOLIZATION INTO THE LEFT PRE AND POST CENTRAL GYRUS ARTERIES. 20 MCG/KG OF IV TIROFIBAN BOLUS WAS ADMINISTERED. FOLLOW-UP RIGHT INTERNAL CAROTID ARTERY CEREBRAL ANGIOGRAM PERFORMED 20 MINUTES LATER SHOWED DISSOLUTION OF THE THROMBI WITH NORMAL ANTEGRADE FILLING OF THE ANTERIOR AND MIDDLE CEREBRAL ARTERIES. THE PATIENT WAS EXTUBATED AND TRANSPORTED TO THE NEUROINTENSIVE CARE UNIT (NICU) IN STABLE CLINICAL AND HEMODYNAMIC CONDITIONS. DIAGNOSTIC CEREBRAL ANGIOGRAM WAS PERFORMED ON (B)(6) 2019. THERE WAS NO EVIDENCE OF ANEURYSMAL SAC OPACIFICATION OF THE PREVIOUSLY COILED RIGHT MIDDLE CEREBRAL ARTERY BIFURCATION TARGET ANEURYSM. THERE WAS RESIDUAL FILLING MEASURING 4.1 X 4.4 X 3.5 MM ANEURYSMAL SAC AT THE NECK OF THE PREVIOUSLY RUPTURED AND COILED NON-TARGET ANTERIOR COMMUNICATING ARTERY ANEURYSM. REPEAT DIAGNOSTIC CEREBRAL ANGIOGRAM WAS PERFORMED ON (B)(6) 2019. THE RIGHT MCA BIFURCATION TARGET ANEURYSM TREATED PREVIOUSLY WITH COIL EMBOLIZATION DEMONSTRATED NO RESIDUAL RECURRENCE (RAYMOND-ROY SCORE WAS 1). THE ANTERIOR COMMUNICATING ARTERY NON-TARGET ANEURYSM PREVIOUSLY TREATED WITH Y-STENTING ASSISTED COIL EMBOLIZATION SHOWED NO RESIDUAL RECURRENCE (RAYMOND-ROY SCORE WAS 1). THERE IS NO NEW INFORMATION THAT ALTERS THE PREVIOUS FILE TYPE DETERMINATION, CODING, AND/OR REPORTABILITY DETERMINATIONS. THIS IS ONE OF 3 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2019-00950, 3008114965-2019-00974, AND 3008114965-2019-00975. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT RACE AND ETHNICITY WERE NOT PROVIDED. PROCODE: PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). (B)(4) [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6) MALE PATIENT WITH A HISTORY OF HEADACHES, HYPERTENSION, AND SUBARACHNOID HEMORRHAGE OF A NON-TARGET ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) ON (B)(6) 2019, UNDERWENT TREATMENT OF A SECOND RIGHT MCA ANEURYSM. ANGIOGRAPHY REVEALED A MULTILOBULATED, IRREGULARLY SHAPED UNRUPTURED ANEURYSM AT THE RIGHT MCA BIFURCATION. THE PARENT VESSEL WAS 2.2 MM, ANEURYSM HEIGHT WAS 5.3 MM, AND THE DOME WAS 3.2 MM. THE MAXIMUM ANEURYSM DIAMETER WAS 5.6 MM, THE ANEURYSM NECK SIZE WAS 3.8 MM, AND THE DOME TO NECK RATIO WAS 0.8. THE PATIENT¿S PRE-PROCEDURE MRS SCORE WAS A 2. THE COIL EMBOLIZATION WAS PERFORMED AND THE 3.5MM X 6.6 CM MICRUSFRAME 10 COIL (MFR100356 / L10260) WAS IMPLANTED. A COUPLE OF THE COIL LOOPS FROM THIS COIL SLIGHTLY MOVED AND BECAME SLIGHTLY PROTRUDED INTO THE PARENT VESSEL. THE PATIENT EXPERIENCED ASYMPTOMATIC THROMBUS FORMATION IN THE RIGHT SUPERIOR MCA THAT WAS PARTIALLY OCCLUSIVE. THE SOURCE OF THE THROMBUS WAS REPORTED TO BE NEAR THE PROTRUDING COIL RESULTING IN THE NARROWING OF THE PARENT VESSEL. THE ADVERSE EVENT WAS CONSIDERED SERIOUS AND WITH A SEVERITY OF SEVERE. THE THROMBUS FORMATION EVENT RESOLVED DURING THE PROCEDURE FOLLOWING TREATMENT WITH UNSPECIFIED MEDICATION AND BALLOON ANGIOPLASTY (SCEPTER XC® BALLOON CATHETER ¿ MICROVENTION). ACCORDING TO THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO STUDY DEVICE. THE FOLLOWING ADDITIONAL COILS: A 2 X 4 CM GALAXY G3 MINI COIL (GLM920040 / L11995), A 2 MM X 6 CM GALAXY G3 MINI COIL (GLM920060 / S15173), A 1.5 MM X 3 CM GALAXY G3 MINI COIL (GLM915030 / L13725), A 2 X 4 CM GALAXY G3 MINI COIL (GLM920040 / L14471), AND A 1.5 MM X 3 CM GALAXY G3 MINI COIL (GLM915030 / L14382) WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH A COMPLETE OBLITERATION OF THE ANEURYSM. THE PATIENT RECEIVED 7000 UNITS HEPARIN DURING THE PROCEDURE. IT WAS REPORTED THAT THE PREVIOUS SUBARACHNOID HEMORRHAGE WAS NOT TREATED WITH CODMAN/CERENOVUS COILS. PRIOR TO THE INDEX PROCEDURE, THE PATIENT TOOK 325 MG OF ASPIRIN ON THE MORNING OF THE PROCEDURE AND 40 MG OF ENOXAPARIN THE DAY BEFORE THE PROCEDURE. THE PATIENT HAD NO HISTORY OF BLOOD CLOTTING ISSUE. THE 3.5MM X 6.6 CM MICRUSFRAME 10 COIL REMAINS IMPLANTED. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L10260) 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. THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH COIL EMBOLIZATION AND IS LISTED IN THE INSTRUCTION FOR USE (IFU) AS SUCH. ACCORDING TO THE LITERATURE, THROMBOEMBOLIC COMPLICATIONS ARE REPORTED IN 5 ¿ 10% OF PATIENTS TREATED ENDOVASCULARLY AND ARE MOST COMMONLY RECOGNIZED AS DISTAL EMBOLI ON ANGIOGRAPHY AND LESS COMMONLY OCCUR WITH A FILLING DEFECT AT THE COIL-BALL/PARENT-ARTERY JUNCTION. THE ROOT CAUSE OF THE THROMBOEMBOLIC EVENT THAT OCCURRED DURING THE INDEX PROCEDURE CANNOT BE DETERMINED; HOWEVER, THE COIL LOOPS FROM THE MICRUSFRAME COIL THAT BECAME SLIGHTLY PROTRUDED INTO THE PARENT ARTERY MAY HAVE CONTRIBUTED TO THE THROMBUS FORMATION. THERE WAS NO REPORT OF VASCULAR INJURY DURING THE PROCEDURE THAT MAY HAVE BEEN A SOURCE OF THE THROMBUS; IT WAS REPORTED THAT THE SOURCE OF THE THROMBUS WAS NEAR THE PROTRUDING COIL RESULTING IN THE NARROWING OF THE PARENT VESSEL. PATIENT, PHARMACOLOGIC AND PROCEDURAL FACTORS MAY HAVE ALSO CONTRIBUTED TO THE EVENT. SINCE THE EVENT RESULTED IN INTERVENTION TO PREVENT LIFE-THREATENING INJURY OR PERMANENT DISABILITY, IT MEETS MDR REPORTING CRITERIA. THIS IS ONE OF 3 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2019-00974, AND 3008114965-2019-00975. 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 HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6) MALE PATIENT WITH A HISTORY OF HEADACHES, HYPERTENSION, AND SUBARACHNOID HEMORRHAGE OF A NON-TARGET ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) ON (B)(6) 2019, UNDERWENT TREATMENT OF A SECOND RIGHT MCA ANEURYSM. ANGIOGRAPHY REVEALED A MULTILOBULATED, IRREGULARLY SHAPED UNRUPTURED ANEURYSM AT THE RIGHT MCA BIFURCATION. THE PARENT VESSEL WAS 2.2 MM, ANEURYSM HEIGHT WAS 5.3 MM, AND THE DOME WAS 3.2 MM. THE MAXIMUM ANEURYSM DIAMETER WAS 5.6 MM, THE ANEURYSM NECK SIZE WAS 3.8 MM, AND THE DOME TO NECK RATIO WAS 0.8. THE PATIENT¿S PRE-PROCEDURE MRS SCORE WAS A 2. THE COIL EMBOLIZATION WAS PERFORMED AND THE 3.5MM X 6.6 CM MICRUSFRAME 10 COIL (MFR100356 / L10260) WAS IMPLANTED. A COUPLE OF THE COIL LOOPS FROM THIS COIL SLIGHTLY MOVED AND BECAME SLIGHTLY PROTRUDED INTO THE PARENT VESSEL. THE PATIENT EXPERIENCED ASYMPTOMATIC THROMBUS FORMATION IN THE RIGHT SUPERIOR MCA THAT WAS PARTIALLY OCCLUSIVE. THE SOURCE OF THE THROMBUS WAS REPORTED TO BE NEAR THE PROTRUDING COIL RESULTING IN THE NARROWING OF THE PARENT VESSEL. THE ADVERSE EVENT WAS CONSIDERED SERIOUS AND WITH A SEVERITY OF SEVERE. THE THROMBUS FORMATION EVENT RESOLVED DURING THE PROCEDURE FOLLOWING TREATMENT WITH UNSPECIFIED MEDICATION AND BALLOON ANGIOPLASTY (SCEPTER XC® BALLOON CATHETER ¿ MICROVENTION). ACCORDING TO THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO STUDY DEVICE. THE FOLLOWING ADDITIONAL COILS: A 2 X 4 CM GALAXY G3 MINI COIL (GLM920040 / L11995), A 2 MM X 6 CM GALAXY G3 MINI COIL (GLM920060 / S15173), A 1.5 MM X 3 CM GALAXY G3 MINI COIL (GLM915030 / L13725), A 2 X 4 CM GALAXY G3 MINI COIL (GLM920040 / L14471), AND A 1.5 MM X 3 CM GALAXY G3 MINI COIL (GLM915030 / L14382) WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH A COMPLETE OBLITERATION OF THE ANEURYSM. THE PATIENT RECEIVED 7000 UNITS HEPARIN DURING THE PROCEDURE. IT WAS REPORTED THAT THE PREVIOUS SUBARACHNOID HEMORRHAGE WAS NOT TREATED WITH CODMAN/CERENOVUS COILS. PRIOR TO THE INDEX PROCEDURE, THE PATIENT TOOK 325 MG OF ASPIRIN ON THE MORNING OF THE PROCEDURE AND 40 MG OF ENOXAPARIN THE DAY BEFORE THE PROCEDURE. THE PATIENT HAD NO HISTORY OF BLOOD CLOTTING ISSUE. THE 3.5MM X 6.6 CM MICRUSFRAME 10 COIL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261867 MICRUSFRAME10 3.5MM X 6.6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 MFR100356 L10260 10886704077794

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other