BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASHMERE 14 - PLATINUM MICROCOIL

    MDR report key: 2591156 · Received May 29, 2012

    Report

    Report Number
    2954740-2012-00572
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 20, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION, THERE WAS NO EVENT OR PRODUCT MALFUNCTION ASSOCIATED WITH THE DEVICE, AND THEREFORE DOES NOT MEET THE CRITERIA FOR REPORTING. ADDITIONALLY, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    FOUR MONTHS AFTER DIAGNOSTIC PRE-OP, CT SCAN SHOWED A REGULARLY SHAPED UNRUPTURED RIGHT OPHTHALMIC-ICA ANEURYSM THAT MEASURED 5.6X3.6X2.3 (NECK) MM. THE PRE-PROCEDURE MRS = 0. IT WAS REPORTED VIA THE PSAS STUDY THAT DURING THE COIL EMBOLIZATION OF THIS ANEURYSM A 5 MM X 14 MICRUSPHERE XL 10 COIL PLACEMENT WAS ATTEMPTED BUT DUE TO ANEURYSM MORPHOLOGY, LOOPS KEPT PROLAPSING INTO THE PARENT VESSEL. THEREFORE, A 4 MM X 7 MM HYPERFORM BALLOON WAS ADVANCED OVER AN X-PEDION 10 TO BRIDGE THE ANEURYSM NECK WHILE THE 10 MICROCATHETER WAS PARKED AT THE ANEURYSM FUNDUS. AFTER THAT, TWO CASHMERE 14.3 MM X 6 CM COILS WERE DEPLOYED. BEFORE DETACHING THE LAST COIL, THE BALLOON WAS DEFLATED TO MAKE SURE THAT THE COIL HAD A SECURE POSITION. AS THE MICROCATHETER WAS BEING PULLED OUTSIDE THE ANEURYSM, A LOOP PROLAPSED FROM THE LAST COIL INTO A PARENT VESSEL. THE SITE INDICATED THAT THE ANEURYSM MORPHOLOGY CONTRIBUTED TO PROLAPSED COIL AFTER BALLOON ASSISTED COILING. THE PATIENT WAS LOADED WITH REPRO AND A 4 X 20 MM SOLITAIRE STENT WAS DEPLOYED ACROSS THE NECK OF THE ANEURYSM. THE STENT WAS SUCCESSFULLY DETACHED AND AN ANGIOGRAM SHOWED NO PULSATION OF THE PROLAPSED COIL OR THE COIL MASS. NO DISTAL THROMBOEMBOLIC EVENT WAS SEEN. RAYMOND ROY GRADING SCALE POST COILING WAS 1 (NO RESIDUAL FILLING OF THE ANEURYSM NECK OR DOME). THE PATIENT RECEIVED REOPRO, ASA AND PLAVIX AT END OF PROCEDURE. IT WAS INDICATED THAT PATIENT'S PRESENT CONDITION WAS BACK TO BASELINE AND WAS DISCHARGED HOME ON PLAVIX. MRS AT DISCHARGE = 0. NO DIAGNOSTIC SCANS WERE TAKEN AT DISCHARGE. SITE INDICATED EVENT WAS PROCEDURAL RELATED BUT NOT RELATED TO THE STUDY DEVICE. THE MEDICAL MONITOR INDICATED EVENT IS RELATED TO THE PROCEDURE BUT NOT RELATED TO THE STUDY DEVICE. THE COILS REMAIN IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS 3 MM X 6 CM CASHMERE 14 PLATINUM MICROCOIL LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS 5 MM X 14 MICRUSPHERE XL 10 LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH REVIEW OF THE AVAILABLE INFORMATION AND AS REPORTED, CLINICAL FACTORS INCLUDING THE ANEURYSM MORPHOLOGY CONTRIBUTED TO THE LOOPS OF THE COIL LOOPS PROLAPSING INTO THE PARENT VESSEL DURING PLACEMENT. THIS AND DEVICE INTERACTION ALSO CONTRIBUTED TO THE PROTRUSION OF THE LAST COIL. WITH REVIEW OF THE REPORTED INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2012-00570, 2954740-2012-00571, 2954740-2012-00572.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: EV3 HYPERFORM, 5 MM X 14 CM MICRUSPHERE XL 10, TWO CASHMERE 14.3 MM X 6 CM COILS, CASHMERE 14.3 MM X 6 CM COIL. NOTE : NO PATIENT CODE LISTED FOR "PROTRUSION INTO THE PARENT VESSEL." THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2012-00570, 2954740-2012-00571, 2954740-2012-00572. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    PER RECEIVED COMPLAINT: COIL PROLAPSED INTO PARENT VESSEL, REQUIRED STENTING AS BAIL OUT. DIAGNOSTIC PRE-OP CT SCAN DONE SHOWED AN UNRUPTURED RIGHT OPHTHALMIC-ICA ANEURYSM. THE SUBJECT'S PRE-OP MRS = 0. THE REGULARLY SHAPED ANEURYSM OF THE OPHTHALMIC WAS 5.6 X 3.6 X 2.3 (NECK) MM. THREE COILS WERE PLACED WITH BALLOON-ASSIST (EV3 HYPERFORM). DURING COIL PLACEMENT AN EXCELSIOR SL-10 MICROCATHETER WAS ADVANCED UNDER ROADMAP GUIDANCE OVER A SYNCHRO2 SOFT MICROWIRE AND POSITIONED IN THE ANEURYSM FUNDUS. A 5 MM X 14 MICRUSPHERE XL 10 COIL PLACEMENT WAS ATTEMPTED BUT DUE TO ANEURYSM MORPHOLOGY, LOOPS KEPT PROLAPSING INTO THE PARENT VESSEL. THEREFORE, A 4 MM X 7 MM HYPERFORM BALLOON WAS ADVANCED OVER AN X-PEDION 10 TO BRIDGE THE ANEURYSM NECK WHILE THE 10 MICROCATHETER WAS PARKED AT THE ANEURYSM FUNDUS. THE FIRST COIL DEPLOYED WAS 5 MM X 14 CM MICRUSPHERE XL 10. AFTER THAT, TWO CASHMERE 14.3 MM X 6 CM COILS WERE DEPLOYED. BEFORE DETACHING THE LAST COIL, THE BALLOON WAS DEFLATED TO MAKE SURE THAT THE COIL HAD A SECURE POSITION. EVENT: AS THEY WERE PULLING THE MICROCATHETER OUTSIDE THE ANEURYSM, A LOOP PROLAPSED FROM THE LAST COIL INTO A PARENT VESSEL. NEURO-INTERVENTIONAL TEAM DECIDED TO STENT ACROSS OF THE ANEURYSM NECK. SITE INDICATES THAT THE ANEURYSM MORPHOLOGY CONTRIBUTED TO PROLAPSED COIL AFTERBALLOON ASSISTED COILING. SUBJECT WAS LOADED WITH REPRO AT THAT POINT. A 4 X 20 MM SOLITAIRE STENT WAS DEPLOYED. THE STENT WAS SUCCESSFULLY DETACHED AND AN ANGIOGRAM SHOWED NO PULSATION OF THE PROLAPSED COIL OR THE COIL MASS. NO DISTAL THROMBOEMBOLIC EVENT WAS SEEN. RAYMOND ROY GRADING SCALE POST COILING WAS 1 (NO RESIDUAL FILLING OF THE ANEURYSM NECK OR DOME). SUBJECT RECEIVED REOPRO, ASA AND PLAVIX AT END OF PROCEDURE. IT WAS INDICATED THAT PATIENT'S PRESENT CONDITION WAS BACK TO BASELINE. SUBJECT WAS DISCHARGED HOME ON PLAVIX. MRS AT DISCHARGE = 0. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASHMERE 14 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G15374

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening