BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 2954048 · Received February 11, 2013

    Report

    Report Number
    1226348-2013-20013
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY A MONTH PRIOR TO THE INDEX PROCEDURE, A DIAGNOSTIC CT SCAN SHOWED EVIDENCE OF A GIANT 21 X 21 X 17 MM BASILAR TIP ANEURYSM WITH SYMPTOMS. THE UNRUPTURED ANEURYSM WAS TREATED A MONTH AFTER WITH THE CODMAN COILS WITH AN ENTERPRISE STENT AS ADJUNCTIVE THERAPY. POST-OP RAYMOND SCORE WAS 3. THE HOSPITAL COURSE WAS UNREMARKABLE AND THE SUBJECT WAS DISCHARGED HOME THREE DAYS AFTER THE PROCEDURE WITH A MRS OF 1. SUBJECT RETURNED FOR 1 MONTH VISIT AND WAS DOING VERY WELL WITH NO NEUROLOGICAL SYMPTOMS, MRS 1. SIS MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT COMPLETED A FOLLOW UP ANGIOGRAM WITH IMPROVEMENT OF RAYMOND SCORE TO A GRADE 2 WITH NO COMPLAINTS OF NEUROLOGICAL SYMPTOMS, AND WAS SCHEDULED FOR AN ADDITIONAL FOLLOW UP ANGIOGRAM AT 1 YEAR. HOWEVER, DESPITE SEVERAL ATTEMPTS, THE PATIENT DID NOT RETURN FOR FOLLOW UP VISIT. A LIST OF THE IMPLANTED COILS CONSISTED OF 3 PRESIDIO MICROCOILS (PC418184630/F60162, PC4181750-30/ F59566, AND PC4181447-30/ G13434), 11 CASHMERE MICROCOILS (CRC141230-30/ F40665, CRC141230-30/ F59807, CRC141025-30/ F59980, CRC140922-30/ F48336, CRC140820-30/ G12321, CRC140820-30/ F59968. CRC140717-30/ F59741, CRC140717-30/G10761, AND X2-CRC140512-30/ G12959), AND 4-DELTAPAQ MICROCOILS (CDF100720-30/ F50669, CDF100616-30/ F47915, CDF100515-30/ G12251, AND CDF100410-30/ G11901), HOWEVER IT IS NOT POSSIBLE TO KNOW WHICH COIL IF ANY OF THE COILS CAUSED THE EVENT. THEREFORE, WE ARE SUBMITTING A MEDWATCH REPORT WITH ONE OF THE COILS AND LISTING THE 17 REMAINING COILS). ADDITIONALLY, IT WAS REPORTED BY THE MEDICAL DIRECTOR AND PHYSICIAN THAT THE EVENT WAS UNRELATED TO THE DEVICES. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. PLEASE NOTE THAT THE CODE ENTERED IN D 4 REPRESENT THE FOLLOWING COILS IMPLANTED/USED TO TREAT THE PATIENT (DELTAPAQ MICROCOILS-CDF100720-30/ F50669, CDF100616-30/ F47915, CDF100515-30/ G12251, AND CDF100410-30/ G11901). THE COILS ARE ALL BEING REPORTED UNDER ONE MEDWATCH REPORT SINCE IT IS NOT KNOWN IF ONE OR ANY WERE INVOLVED IN THE EVENT. THIS IS 4 PRODUCTS OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1226348-2013-20011, 1226348-2013-20012 AND 1226348-2013-20013. THE PRODUCTS REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE (B)(6) STUDY REPORTED THAT PATIENT WITH ID# (B)(6) RETURN EIGHTEEN MONTHS AFTER THE INDEX PROCEDURE FOR AN ANEURYSM OF THE BASILAR TIP ANEURYSM TREATED WITH AN ENTERPRISE AND 18 CODMAN MICROCOILS (3 PRESIDIO, 11 CASHMERE, AND 4 DELTAPAQ-SEE SECTION H 10), THE SUBJECT PRESENTED TO ER LETHARGIC, NOT FOLLOWING COMMANDS WITH PURPOSEFUL MOVEMENT ON THE LEFT AND HEMIPARESIS ON THE RIGHT. THE SUBJECT WAS FOUND TO HAVE SAH AND INTRAVENTRICULAR HEMORRHAGE WITH INVOLVEMENT OF THE LEFT THALAMUS AND WITH CORRESPONDING RIGHT HEMIPARESIS AND UNDERWENT THE PLACEMENT OF EXTERNAL VENTRICULOSTOMY DRAIN CATHETER. THE FOLLOWING DAY AFTER ONSET, THE SUBJECT UNDERWENT RE-COILING OF THE RUPTURED BASILAR TIP ANEURYSM WHICH WAS COMPLICATED BY TRANSIENT BASILAR OCCLUSION THAT WAS RECANALIZED WITH IA REOPRO AND PENUMBRA SUCTION ASPIRATION. THE THROMBOSIS WAS NOT WITHIN 5MM OF THE ENTERPRISE STENT, AND THE PATIENT DOES NOT HAVE A HISTORY OF HYPERCOAGULATION. THE VESSEL DIAMETER PROXIMALLY WAS 3.2 MM AND ABOUT 2 MM DISTAL WHERE STENT LANDED. THE SUBJECT WAS TAKEN TO THE NICU POST-OP WHERE SHE WAS FOLLOWING COMMANDS ON THE LEFT WITH RIGHT HEMIPARESIS. SIX DAYS AFTER THE ADMISSION, THE SUBJECT NEUROLOGICAL EXAM SHOWED INTERMITTENTLY FOLLOWING COMMANDS ON THE LEFT; HEMIPARETIC ON THE RIGHT AND NONVERBAL. THE EVD IS STILL IN PLACE AND PATENT. THE SUBJECT WAS EXTUBATED ON ROOM AIR. THE TREATING PHYSICIAN INDICATED THE EVENT WAS NOT RELATED TO CODMAN DEVICES OR PROCEDURE, AND THE MEDICAL MONITOR INDICATED EVENT (SAH) IS NOT RELATED TO THE CODMAN DEVICES OR PROCEDURE. APPROXIMATELY A MONTH PRIOR TO THE INDEX PROCEDURE, A DIAGNOSTIC CT SCAN SHOWED EVIDENCE OF A GIANT 21 X 21 X 17 MM BASILAR TIP ANEURYSM WITH SYMPTOMS. THE UNRUPTURED ANEURYSM WAS TREATED A MONTH AFTER WITH THE CODMAN COILS WITH AN ENTERPRISE STENT AS ADJUNCTIVE THERAPY. POST-OP RAYMOND SCORE WAS 3. THE HOSPITAL COURSE WAS UNREMARKABLE AND THE SUBJECT WAS DISCHARGED HOME THREE DAYS AFTER THE PROCEDURE WITH A MRS OF 1. SUBJECT RETURNED FOR 1 MONTH VISIT AND WAS DOING VERY WELL WITH NO NEUROLOGICAL SYMPTOMS, MRS 1. SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT COMPLETED A FOLLOW UP ANGIOGRAM WITH IMPROVEMENT OF RAYMOND SCORE TO A GRADE 2 WITH NO COMPLAINTS OF NEUROLOGICAL SYMPTOMS, AND WAS SCHEDULED FOR AN ADDITIONAL FOLLOW UP ANGIOGRAM AT 1 YEAR. HOWEVER, DESPITE SEVERAL ATTEMPTS THE PATIENT DID NOT RETURN FOR FOLLOW UP VISIT. A LIST OF THE IMPLANTED COILS CONSISTED OF 3 PRESIDIO MICROCOILS ((B)(4), (B)(4), AND (B)(4)), 11 CASHMERE MICROCOILS ((B)(4)), AND 4-DELTAPAQ MICROCOILS ((B)(4)), HOWEVER IT IS NOT POSSIBLE TO KNOW WHICH COIL IF ANY OF THE COILS CAUSED THE EVENT. THEREFORE, WE ARE SUBMITTING A MEDWATCH REPORT WITH ONE OF THE COILS AND LISTING THE 17 REMAINING COILS IN THIS SECTION. ADDITIONALLY, IT WAS REPORTED BY THE MEDICAL DIRECTOR AND PHYSICIAN THAT THE EVENT WAS UNRELATED TO THE DEVICES. MEDICATIONS CONSISTED OF 369.4 MCG OF REMIFENTANIL INFUSION, 3 UNITS OF VASOPRESSIN BOLUS IV, 300 MCG OF PHENYLEPHRINE IV, 10 MG OF EPHEDRINE IV,3 MG OF NEOSTIGMINE IV,0.6 MG OF GLYCOPYRROLATE IV. THE FOLLOWING DHR'S WERE REVIEWED WITH NO ISSUES FOUND; (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ANEURYSM RUPTURE IS A KNOWN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH COIL EMBOLIZATIONS AND THE USE OF THE ENTERPRISE VRD IN INTRACRANIAL ARTERIES AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH PROCEDURAL IMAGES ARE NOT AVAILABLE, IT APPEARS THAT VESSEL CHARACTERISTICS, DEVICE MANIPULATION/CONCOMITANT DEVICES, AND DEVICE INTERACTION DUE TO THE UTILIZED COILING TECHNIQUE CONTRIBUTED TO THE REPORTED EVENT. ARTERIAL EMBOLIZATION PROCEDURES ARE PERFORMED IN VESSELS WITH EXISTING ANEURYSMS AND KNOWN VESSEL WALL WEAKNESS. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED RUPTURE WITH NO INDICATION OF ANY ENTERPRISE DEVICE PERFORMANCE OR MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COILS ARE ALL BEING REPORTED UNDER ONE MEDWATCH REPORT SINCE IT IS NOT KNOWN IF ONE OR ANY WERE INVOLVED IN THE EVENT. THESE ARE 4 PRODUCTS OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1226348-2013-20011, 1226348-2013-20012, 1226348-2013-20013, AND 1058196-2013-00046.

    Description of Event or Problem · 1

    THE (B)(4) STUDY REPORTED THAT PATIENT WITH (B)(6) RETURN EIGHTEEN MONTHS AFTER THE INDEX PROCEDURE FOR AN ANEURYSM OF THE BASILAR TIP ANEURYSM TREATED WITH AN ENTERPRISE AND 18 CODMAN MICROCOILS (3 PRESIDIO, 11 CASHMERE, AND 4 DELTAPAQ), THE SUBJECT PRESENTED TO ER LETHARGIC, NOT FOLLOWING COMMANDS WITH PURPOSEFUL MOVEMENT ON THE LEFT AND HEMIPARESIS ON THE RIGHT. THE SUBJECT WAS FOUND TO HAVE SAH AND INTRAVENTRICULAR HEMORRHAGE WITH INVOLVEMENT OF THE LEFT THALAMUS AND WITH CORRESPONDING RIGHT HEMIPARESIS AND UNDERWENT THE PLACEMENT OF EXTERNAL VENTRICULOSTOMY DRAIN CATHETER. THE FOLLOWING DAY AFTER ONSET, THE SUBJECT UNDERWENT RE-COILING OF THE RUPTURED BASILAR TIP ANEURYSM WHICH WAS COMPLICATED BY TRANSIENT BASILAR OCCLUSION THAT WAS RECANALIZED WITH IA REOPRO AND PENUMBRA SUCTION ASPIRATION. THE SUBJECT WAS TAKEN TO THE NICU POST-OP WHERE SHE WAS FOLLOWING COMMANDS ON THE LEFT WITH RIGHT HEMIPARESIS. SIX DAYS AFTER THE ADMISSION, THE SUBJECT NEUROLOGICAL EXAM SHOWED INTERMITTENTLY FOLLOWING COMMANDS ON THE LEFT; HEMIPARETIC ON THE RIGHT AND NONVERBAL. THE EVD IS STILL IN PLACE AND PATENT. THE SUBJECT WAS EXTUBATED ON ROOM AIR. THE TREATING PHYSICIAN INDICATED THE EVENT WAS NOT RELATED TO CODMAN DEVICES OR PROCEDURE, AND THE MEDICAL MONITOR INDICATED EVENT (SAH) IS NOT RELATED TO THE CODMAN DEVICES OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58357 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R