BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 3231520 · Received July 17, 2013

    Report

    Report Number
    1226348-2013-20131
    Event Type
    Death
    Date Received
    July 17, 2013
    Report Date
    September 6, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FROM (B)(6) CLINICAL STUDY FOR PATIENT WITH ID# (B)(6) INDICATED THAT THE INDEX PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452812/01427228), CODMAN COILS (CASHMERE MICROCOILS-CRC141230-30/G12198 TOTAL 2, CRC141127-30/G11123, CRC141025-30/G12262, CRC140922-30/G12077, CRC140922-30/G11411, CRC140820-30/G12213 & DELTAPLUSH MICROCOILS (CPL100206-30/G13002 TOTAL 4, CPL100206-30/G13338, CPL100206-30/G12830 TOTAL 4, CPL100206-30/G12227), AND NON-CODMAN COILS OF THE LEFT POSTERIOR COMMUNICATING ARTERY, THE PHYSICIAN CONFIRMED THAT THE PATIENT DIED TWENTY ONE-MONTHS AFTER THE INDEX PROCEDURE, BUT THE DATE AND CAUSE WERE UNKNOWN. ADDITIONALLY, DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT WHILE INSERTING THE GUIDING CATHETER (SHUTTLE SHEATH/COOK INC), THE PATIENT DEVELOPED AN ACUTE AORTIC DISSECTION FROM LEFT COMMON CAROTID ARTERY TOWARD ASCENDING AORTA. THE PATIENT ALSO DEVELOPED THE LEFT DROOPY EYELID. BAIL OUT STENTING WAS PERFORMED FOR SEALING OFF THE ACUTE AORTIC DISSECTION, WHEREAS ACTION TAKEN FOR THE LEFT DROOPY EYELID WAS THE ADMINISTRATION OF MECOBALAMIN. THE OUTCOME OF THE ACUTE AORTIC DISSECTION WAS RESOLVED WITHOUT SEQUEALE, AND OF THE DROOPY EYELID WAS ONGOING & IMPROVED. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE ACUTE AORTIC DISSECTION TO THE PROCEDURE WAS RELATED AND THE DROOPY EYELID WAS UNKNOWN, BUT THE RELATIONSHIPS OF BOTH THE EVENTS TO THE VRD WERE UNRELATED. THE POSSIBLE CAUSE OF THE ACUTE AORTIC DISSECTION WAS CONSIDERED TO BE A COMPLICATION ASSOCIATED WITH THE INSERTION OF THE GUIDING CATHETER. THE POSSIBLE CAUSE OF THE LEFT DROOPY EYELID WAS THE ANEURYSM PRESSING ON THE OCULOMOTOR NERVE. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 8.4MM, AND THE NECK TO SAC RATIO WAS 8.4MM:11.9MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.9MM AND DISTALLY WAS 2.8MM. MRS ON (B)(6) 2011 WAS 2. THE ACT WAS 102 SECONDS PRE ANTICOAGULATION AND 257 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 100% AFTER THE PROCEDURE. THE 1-YEAR FOLLOW-UP WAS TOOK PLACE ON (B)(6) 2012, ANEURYSM NECK WAS 8.4MM, AND THE NECK TO SAC RATIO WAS 8.4MM:11.9MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.9MM AND DISTALLY WAS 2.8MM. THE OCCLUSION RATE OF ANEURYSM WAS 90%. MRS WAS 1. THE 2-YEAR FOLLOW-UP WAS NOT CONDUCTED DUE TO THE DEATH OF THE PATIENT. MRS WAS 6. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2011, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011 ~ ONGOING, HEPARIN 7000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, THYROIDITIS AND OCULOMOTOR PARALYSIS. PRIOR TO IMPLANTING THE VRD, DEVICES USED CONSISTED OF SHUTTLE SHEATH 7FR 90CM/COOK INC, PROWLER SELECT PLUS (MC) MICROCATHETER (606-S255X, 15268746), CHIKAI 200CM 0.014INCH/ASAHI INTECC WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10 MC (TYPE STR)/STRYKER, SYNCHRO 2 200CM 0.014INCH/STRYKER, EXTENSION NV 165CM 0.014INCH/ASAHI INTECC, HYPERGLIDE/COVIDIEN (B)(4), HYPERFORM/COVIDIEN (B)(4), CASHMERE MICROCOILS (CRC141230-30/G12198 TOTAL 2, CRC141127-30/G11123, CRC141025-30/G12262, CRC140922-30/G12077, CRC140922-30/G11411, CRC140820-30/G12213), DELTAPLUSH MICROCOILS (CPL100206-30/G13002 TOTAL 4, CPL100206-30/G13338, CPL100206-30/G12830 TOTAL 4, CPL100206-30/G12227), ED INFINI(16MM X 30CM TOTAL 7)/KANEKA, V-TRACK HYDROCOIL 10(6MM X 10CM TOTAL 3, 5MM X 10CM TOTAL 2, 4MM X 10CM, 3MM X 6CM TOTAL 7, 3MM X 4CM TOTAL 2, 2MM X 6CM TOTAL 4, 2MM X 4CM)/TERUMO. DURING THE PROCEDURE, JAILED TECHNIQUE AND BALLOON ASSISTED TECHNIQUE WERE UTILIZED. THE 2-YEAR FOLLOW-UP WAS NOT CONDUCTED DUE TO THE DEATH OF THE PATIENT. MRS WAS 6. THE PHYSICIAN CONFIRMED THAT THE PATIENT DIED BUT THE DATE UNKNOWN. ALSO THE CAUSE OF THE DEATH WAS UNKNOWN. ALL THE DEVICES REMAINED IMPLANTED AND WERE NOT AVAILABLE FOR ANALYSES, ADDITIONALLY THE LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427228. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE DHR FOR THE COILS INDICATED THAT REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE PATIENT PROCEDURAL OUTCOME AND SUBSEQUENT DEATH. ADDITIONALLY, THE DHR INDICATED THAT ALL THE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT, THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    PRIOR TO IMPLANTING THE VRD, DEVICES USED CONSISTED OF SHUTTLE SHEATH 7FR 90CM/COOK INC, PROWLER SELECT PLUS (MC) MICROCATHETER (606-S255X, 15268746), CHIKAI 200CM 0.014INCH/ASAHI INTECC WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10 MC (TYPE STR)/STRYKER, SYNCHRO 2 200CM 0.014INCH/STRYKER, EXTENSION NV 165CM 0.014INCH/ASAHI I(B)(4), HYPERGLIDE/COVIDIEN (B)(4), HYPERFORM/COVIDIEN (B)(4), CASHMERE MICROCOILS (CRC141230-30/G12198 TOTAL 2, CRC141127-30/G11123, CRC141025-30/G12262, CRC140922-30/G12077, CRC140922-30/G11411, CRC140820-30/G12213), DELTAPLUSH MICROCOILS (CPL100206-30/G13002 TOTAL 4, CPL100206-30/G13338, CPL100206-30/G12830 TOTAL 4, CPL100206-30/G12227), ED INFINI(16MM X 30CM TOTAL 7)/KANEKA, V-TRACK HYDROCOIL 10(6MM X 10CM TOTAL 3, 5MM X 10CM TOTAL 2, 4MM X 10CM, 3MM X 6CM TOTAL 7, 3MM X 4CM TOTAL 2, 2MM X 6CM TOTAL 4, 2MM X 4CM)/TERUMO. DURING THE PROCEDURE, JAILED TECHNIQUE AND BALLOON ASSISTED TECHNIQUE WERE UTILIZED. THIS REPORT IS FOR 10 DELTAPLUSH MICROCOILS, SINCE IT IS UNKNOWN WHICH COIL IF ANY, WAS INVOLVED IN THE EVENT. THE EVENT DATE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE REPORT FROM (B)(6) STUDY FOR PATIENT WITH ID# (B)(6) INDICATED THAT THE INDEX PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452812/01427228), CODMAN COILS (CASHMERE MICROCOILS-CRC141230-30/G12198 TOTAL 2, CRC141127-30/G11123, CRC141025-30/G12262, CRC140922-30/G12077, CRC140922-30/G11411, CRC140820-30/G12213 & DELTAPLUSH MICROCOILS (CPL100206-30/G13002 TOTAL 4, CPL100206-30/G13338, CPL100206-30/G12830 TOTAL 4, CPL100206-30/G12227), AND NON-CODMAN COILS OF THE LEFT POSTERIOR COMMUNICATING ARTERY, THE PHYSICIAN CONFIRMED THAT THE PATIENT DIED TWENTY ONE-MONTHS AFTER THE INDEX PROCEDURE, BUT THE DATE AND CAUSE WERE UNKNOWN. ADDITIONALLY, DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT WHILE INSERTING THE GUIDING CATHETER (SHUTTLE SHEATH/COOK INC), THE PATIENT DEVELOPED AN ACUTE AORTIC DISSECTION FROM LEFT COMMON CAROTID ARTERY TOWARD ASCENDING AORTA. THE PATIENT ALSO DEVELOPED THE LEFT DROOPY EYELID. BAIL OUT STENTING WAS PERFORMED FOR SEALING OFF THE ACUTE AORTIC DISSECTION, WHEREAS ACTION TAKEN FOR THE LEFT DROOPY EYELID WAS THE ADMINISTRATION OF MECOBALAMIN. THE OUTCOME OF THE ACUTE AORTIC DISSECTION WAS RESOLVED WITHOUT SEQUEALE, AND OF THE DROOPY EYELID WAS ONGOING & IMPROVED. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE ACUTE AORTIC DISSECTION TO THE PROCEDURE WAS RELATED AND THE DROOPY EYELID WAS UNKNOWN, BUT THE RELATIONSHIPS OF BOTH THE EVENTS TO THE VRD WERE UNRELATED. THE POSSIBLE CAUSE OF THE ACUTE AORTIC DISSECTION WAS CONSIDERED TO BE A COMPLICATION ASSOCIATED WITH THE INSERTION OF THE GUIDING CATHETER. THE POSSIBLE CAUSE OF THE LEFT DROOPY EYELID WAS THE ANEURYSM PRESSING ON THE OCULOMOTOR NERVE. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331525 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death