BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2954021 · Received February 11, 2013

    Report

    Report Number
    1058196-2013-00033
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    July 11, 2011
    Report Date
    December 25, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 4.5MM, AND THE NECK TO SAC RATIO WAS 4.5MM:7.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.0MM AND DISTALLY WAS 3.0MM. THE MRS BEFORE THE PROCEDURE THE DATE OF THE PROCEDURE 11 WAS 0, ON (B)(6) 2011 WAS 0, ON (B)(6) 2011 WAS 0. NO INFORMATION REGARDING ACT, INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 100% AFTER THE PROCEDURE. NO INFORMATION WAS PROVIDED ABOUT THE SIZE OF THE VESSEL AT THE TIME OF FOLLOW-UP CONDUCTED AT SEVENTEEN MONTHS POST PROCEDURE. AT THE TIME OF ONE YEAR FOLLOW UP ON CONDUCTED A YEAR AFTER THE INDEX PROCEDURE, THE OCCLUSION RATE OF ANEURYSM WAS 100% AND MRS WAS 0. THE PATIENT'S MEDICAL CONSISTED OF HYPERTENSION. MEDICATIONS GIVEN CONSISTED OF HEPARIN7,500U DURING THE INDEX PROCEDURE, ASPIRIN 100MG/DAY AND CLOPIDOGREL SULFATE 100MG/DAY DURING THE INDEX PROCEDURE AND ONGOING,. PRIOR TO IMPLANTING THE VRD, A 5FRENCH ENVOY CATHETER (CATALOGUE AND LOT UNKNOWN), SELECT PLUS MICROCATHETER (606-S255FX/LOT UNKNOWN) , X-CELERATOR HYDROPHILIC GW (COVIDIEN (B)(4)) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE EXCELSIOR SL10 MICROCATHETER, SILVERSPEED (COVIDIEN (B)(4)), TRANSCEND (STRYKER), AND CASHMERE MICROCOIL (CSP10050030/LOT UNKNOWN). PROCEDURAL IMAGES ARE NOT AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: ENVOY(5FR, CATALOGUE AND LOT UNKNOWN), 606-S255FX(LOT UNKNOWN) , X-CELERATOR HYDROPHILIC GW/COVIDIEN (B)(4) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE EXCELSIOR SL10, SILVERSPEED/COVIDIEN (B)(4), TRANSCEND/STRYKER, CSP10050030(LOT UNKNOWN). THE PATIENT'S MEDICAL CONSISTED OF HYPERTENSION. MEDICATIONS GIVEN CONSISTED OF HEPARIN7,500U DURING THE INDEX PROCEDURE, ASPIRIN 100MG/DAY AND CLOPIDOGREL SULFATE 100MG/DAY DURING THE INDEX PROCEDURE AND ONGOING,. PRIOR TO IMPLANTING THE VRD, A 5FRENCH ENVOY CATHETER (CATALOGUE AND LOT UNKNOWN), SELECT PLUS MICROCATHETER (606-S255FX/LOT UNKNOWN) , X-CELERATOR HYDROPHILIC GW (COVIDIEN (B)(4)) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE EXCELSIOR SL10 MICROCATHETER, SILVERSPEED (COVIDIEN (B)(4)), TRANSCEND (STRYKER), AND CASHMERE MICROCOIL (CSP10050030/LOT UNKNOWN). PROCEDURAL IMAGES ARE NOT AVAILABLE. PACKAGING OF LOT 01428092. 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 (B)(4) MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. VESSEL SPASM REACTION MAY OCCUR WHEN POSITIONING/ADVANCING THE DEVICES WITHIN THE ANEURYSM OR THROUGH THE VESSEL/ARTERIES. THIS IS A WELL KNOW POTENTIAL COMPLICATION WITH ANY INVASIVE PROCEDURE DURING WHICH DEVICES ARE BEING USED TO TREAT ANEURYSMS. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEFECT OF THE DEVICE, BUT IS LIKELY RELATED TO VESSEL CHARACTERISTICS, PATIENT AND PROCEDURAL FACTORS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT AND .

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT #210-10 INDICATED THAT DURING THE INDEX PROCEDURE, AFTER THE ENTERPRISE VRD (ENC453712/01428092) WAS IMPLANTED, SPASM OCCURRED IN THE BA-TIP ARTERY DURING PLACEMENT OF MICRUSPHERE MICROCOIL (CSP100500-30, LOT UNKNOWN) USING THE EXCELSIOR SL10 STR MICROCATHETER (STRYKER) WHICH WAS DELIVERED THROUGH THE 5FRENCH ENVOY GUIDE CATHETER (5FR, CATALOGUE AND LOT UNKNOWN). THE EVENT OCCURRED DURING PLACING THE FIRST MICRUSPHERE COIL (CSP10050030, LOT UNKNOWN), AND IT WAS REPORTED THAT NEITHER ENVOY NOR ENTERPRISE CONTRIBUTE TO THE EVENT. THE SL 10 DID NOT LOSE POSITION DUE TO POSITIONING DIFFICULTY WITH THE MICRUSPHERE COIL (CSP100500-30, LOT UNKNOWN). THUS, THE PROCEDURE WAS DISCONTINUED DUE TO THE SPASM. NO ACTION WAS TAKEN. THE EVENT OUTCOME SINCE ONSET WAS RESOLVED WITHOUT SEQUEL. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNRELATED. THE ADDITIONAL COIL EMBOLIZATION TOOK PLACE TWO MONTHS AFTER THE INDEX PROCEDURE WITH NO ISSUES NOTED. IT WAS NOTED THAT THE SPASM MIGHT BE PRODUCED BY PHYSICAL CONTACT WITH THE CATHETERS (UNSPECIFIED) DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58297 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01428092

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR SEE SECTION D 11