BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2921659 · Received January 18, 2013

    Report

    Report Number
    1058196-2013-00020
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MEDICAL HISTORY CONSISTED OF CEREBRAL STROKE AND RETINAL DETACHMENT. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 4.7MM, AND THE NECK TO SAC RATIO WAS 4.7MM:8.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.1MM AND DISTALLY WAS 3.8MM. THE MRS BEFORE THE INDEX PROCEDURE ON (B)(6) 2010 WAS 0, ON (B)(64) 2010 WAS 0, ON (B)(6) 2010 WAS 0. THE ACT WAS 100 SECONDS PRE ANTICOAGULATION AND 286 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 90% AFTER THE INDEX PROCEDURE. AT THE TIME OF ONE YEAR FOLLOW-UP ON (B)(6) 2011, THE ANEURYSM NECK WAS 4.7MM, AND THE NECK TO SAC RATIO WAS 4.7MM:8.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.1MM AND DISTALLY WAS 3.8MM. THE OCCLUSION RATE OF ANEURYSM WAS 90%. THE MRS ON (B)(6) 2011 WAS 0. AT THE TIME OF TWO YEAR FOLLOW-UP ON (B)(6) 2012, THE ANEURYSM NECK WAS 4.7MM, AND THE NECK TO SAC RATIO WAS 4.7MM:8.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.1MM AND DISTALLY WAS 3.8MM. THE OCCLUSION RATE OF ANEURYSM WAS 100%. MRS ON (B)(6) 2012 WAS 0. THE ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2010, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2010 ~ (B)(6) 2011, CILOSTAZOL 200MG/DAY: (B)(6) 2010 ~ (B)(6) 2011, HEPARIN 7,000U ADMINISTERED INTRA-PROCEDURALLY, HEPARIN 12000U: (B)(6) 2010. PRIOR TO IMPLANTING THE VRD AT THE TIME OF INDEX PROCEDURE, GUIDER ST XF/STRYKER, 606-S255X(15168356) AND RADIFOCUS GT GW/TERUMO. OTHER DEVICES UTILIZED DURING THE INDEX PROCEDURE WERE, EXCELSIOR SL10 MICROCATHETER (STRYKER, ED COILS (TOTAL 2), ORBIT COILS (637CF0615/15129001, 638CF0516/15161040, 637MF3575/15120385,AND 637MF3575/15120385). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    REGARDING THE TRANSIENT ISCHEMIC ATTACK, THE PHYSICIAN COMMENTED THAT THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED BECAUSE MORE THAN 15 MONTHS HAD ELAPSED AFTER THE INDEX PROCEDURE. WHEREAS THE RELATIONSHIP OF THE EVENT TO THE VRD WAS HIGHLY PROBABLE AS IT WAS DEVELOPED AFTER DISCONTINUATION OF ANTIPLATELET THERAPY. ANTIPLATELET THERAPY: ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2010 AND (B)(6) 2012, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2010 - (B)(6) 2011 AND (B)(6) 2012 - ONGOING, CILOSTAZOL 200MG/DAY: (B)(6) 2010 - (B)(6) 2011 AND (B)(6) 2012, HEPARIN 7000U ADMINISTERED INTRA-PROCEDURALLY, HEPARIN 12000U: (B)(6) 2010. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT FOR NOW.

    Description of Event or Problem · 1

    THE COMPLAINT IS FROM A CLINICAL STUDY (B)(4) FOR PATIENT WITH ID # (B)(6) INDICATED THAT TWENTY SEVEN MONTHS AFTER THE INDEX PROCEDURE TO TREAT AN ANEURYSM OF THE RIGHT PARASELLAR WITH AND ENTERPRISE VRD(ENC452812/01422404), THE PATIENT COMPLAINED OF EVANESCENT WEAKNESS OF THE ARM AND LOWER-EXTREMITY ASSOCIATED WITH THE TRANSIENT ISCHEMIC ATTACK. ACTION TAKEN WAS ADMINISTRATION OF ASPIRIN, CILOSTAZOL AND CLOPIDOGREL SULFATE. THE EVENT OUTCOME AS OF THE TIME OF ONSET WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNKNOWN AND TO THE VRD WAS HIGHLY PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27668 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01422404

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention