BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3230220 · Received July 16, 2013

    Report

    Report Number
    1058196-2013-00187
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    July 20, 2011
    Report Date
    May 7, 2024
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S MEDICAL HISTORY CONSISTED OF HYPERTENSION, CEREBRAL INFARCTION, MENIERE'S DISEASE AND A CLIPPING OF BA-TIP (DETAILS UNKNOWN). THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 5.4MM, AND THE NECK TO SAC RATIO WAS 5.4MM:6.4MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.0MM AND DISTALLY WAS 2.0MM. MRS ON (B)(6) 2011, WAS 2. THE ACT WAS 119 SECONDS PRE ANTICOAGULATION AND 260 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 90% AFTER THE INDEX PROCEDURE. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2011 TO ONGOING, CLOPIDOGUREL SULFATE 75MG/DAY: (B)(6) 2011 TO ONGOING, ARGATROBAN HYDRATE 20MG/DAY: (B)(6) 2011. HEPARIN 5000U WAS ADMINISTERED INTRA-PROCEDURALLY. PRIOR TO IMPLANTING THE VRD, ENVOY(5FR, 90CM, TYPE AND LOT UNKNOWN, TOTAL 2), PROWLER SELECT PLUS(606-S255FX, LOT UNKNOWN), CHIKAI 14/ASAHI INTECC, TRANSEND 14/STRYKER WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE INDEX PROCEDURE WERE, EXCELSIOR SL10 (TYPE STR)/STRYKER, RADIFOCUS GT 16/TERUMO, ORBIT GALAXY(640CX0408, 640CX3575 TOTAL 2, 640CX2535, 640HX0206, LOT ALL UNKNOWN). DURING THE PROCEDURE, JAILED TECHNIQUE WAS UTILIZED. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(6) FOR PATIENT WITH ID# (B)(6) INDICATED THAT THE INDEX PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH TWO VRD (ENC452212/ 01427238 AND 01429660 , ORBIT GALAXY COILS ((B)(4)/LOT# UNK, (B)(4)/LOT# UNK X2, AND (B)(4)/LOT# UNK) OF THE BA-TIP, AND A COUPLE OF HOURS AFTER THE PROCEDURE, THE PATIENT HAD AN ORIENTATION DISTURBED AS WELL AS DIPLOPIA ASSOCIATED WITH MIDBRAIN INFARCTION. ARGATROBAN HYDRATE WAS ADMINISTRATED FOR TREATMENT. THE EVENT OUTCOME AS OF TIME OF ONSET WAS ONGOING/ IMPROVED. ACCORDING TO THE PHYSICIAN, THE POSSIBLE CAUSE OF THE EVENT WAS THE EFFECT OF THE COIL-ORIGINATED OR VRD-ORIGINATED THROMBOSIS. THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE WHERE AS TO THE VRD WAS UNKNOWN. AT THE TIME OF THE INDEX PROCEDURE , THE FIRST VRD(ENC452212/01427238) WAS INITIALLY PLACED FROM BASILAR ARTERY TO POSTERIOR CEREBRAL ARTERY ALONG THE TARGET ANEURYSM. THEN, THE 2ND VRD (ENC452212/01429660) WAS NAVIGATED INTO BASILAR ARTERY THROUGH 1ST VRD STRUT AND DEPLOYED WITH THE DISTAL END IN THE POSTERIOR CEREBRAL ARTERY AND THE PROXIMAL PORTION OVERLAPPING THE FIRST STENT IN THE BASILAR ARTERY AND THEN, THE COIL EMBOLIZATION WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328859 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01429660

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention SEE SECTION H 10