BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2900292 · Received January 7, 2013

    Report

    Report Number
    1058196-2013-00007
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    November 15, 2011
    Report Date
    December 24, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: INITIAL MDR SUBMISSION INDICATED THAT LOT NUMBER REPORTED WAS 02422610. A CORRECTION IS NOW BEING SUBMITTED TO CORRECT THE LOT# TO 01423722 WHICH HAS A MANUFACTURING DATE OF 06/2010 AND AN EXPIRATION DATE OF 05/2011 . IN ADDITION, THE EVENT DATE AND IMPLANT DATE ARE BEING CORRECTED FROM (B)(6) 2011 PER INITIAL MDR SUBMISSION TO (B)(6) 2010. THESE INFORMATION AND CHANGES WERE REPORTED FROM A REVISED COMPLAINT DATA RECEIVED. INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT APPROXIMATELY ONE YEAR POST ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM ANGIOGRAPHY REVEALED STENOSIS AROUND THE DISTAL MARKERS OF THE VRD. THE PERCENTAGE OF STENOSIS IS NOT KNOWN AND THE PATIENT WAS ASYMPTOMATIC. THE PERCENTAGE OF STENOSIS IS NOT KNOWN AND IT IS NOT KNOWN IF THERE WAS ANY STENOSIS PRESENT PRIOR TO THE INDEX PROCEDURE. IT WAS REPORTED THAT THE ADMINISTRATION OF CLOPIDOGREL SULFATE WAS DISCONTINUED. CILOSTAZOL WAS ADMINISTRATED INSTEAD. THE EVENT OUTCOME TWO MONTHS LATER WAS "RECOVERED WITHOUT SEQUELAE". ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS HIGHLY PROBABLE. THE (B)(6) FEMALE HAS A MEDICAL HISTORY OF UTERINE MYOMA, HYPERTENSION, AND HYPERLIPIDEMIA. AT INDEX PROCEDURE THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 7.9MM, AND THE NECK TO SAC RATIO WAS 7.9 MM: 13.7 MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.7 MM AND DISTALLY WAS 2.9 MM. HEPARIN 5000 U WAS ADMINISTRATED INTRA-PROCEDURALLY ON (B)(6) 2010. THE ACT WAS 106 SECONDS PRE ANTICOAGULATION AND 283 SECONDS POST ANTICOAGULATION. THE OCCLUSION RATE OF ANEURYSM WAS 95% AFTER THE INDEX PROCEDURE. THERE WAS NO CHANGE TO THE ANEURYSM AS COMPARED TO POST INDEX PROCEDURE. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.7MM AND DISTALLY WAS 2.9 MM. A TOTAL OF 21 NONCODMAN COILS WERE PLACED. THE OCCLUSION RATE OF ANEURYSM WAS 95%. HEPARIN 10000 U WAS ADMINISTERED FOR ONE DAY BEGINNING THE DAY OF THE PROCEDURE. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100 MG/DAY ONGOING STARTING THREE DAYS PRE-INDEX PROCEDURE AND CLOPIDOGREL SULFATE 75 MG/DAY: FOR ONE YEAR POST INDEX PROCEDURE FOLLOWED BY CILOSTAZOL 100 MG/DAY FOR ONE YEAR AND CILOSTAZOL 10 MG/DAY BEGINNING THREE DAYS POST INDEX PROCEDURE FOR 10 DAYS AND THEN ONGOING AT THE TIME OF THE NOTED STENOSIS. THE MODIFIED RANKIN SCALE (MRS) SCORE BEFORE THE INDEX PROCEDURE, AFTER THE PROCEDURE, AT ONE YEAR FOLLOW-UP AND ONE MONTH AFTER THE STENOSIS WAS NOTED WAS 0. THE ENTERPRISE VRD REMAINS IMPLANTED AND THEREFORE IS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01423722. 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. STENOSIS OF THE STENTED SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE. THIS PATIENT'S CONCOMITANT MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA AND HYPERTENSION ALONG WITH PROCEDURAL FACTORS MAY HAVE IMPACTED THE EVENT. HOWEVER, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE EVENT. THERE ARE NO INDICATIONS OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    PRIOR TO IMPLANTING THE VRD AT THE TIME OF INDEX PROCEDURE, ROADMASTER/GOODMAN, (B)(4)(LOT#UNKNOWN) AND CHIKAI/ASAHI INTEC WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE INDEX PROCEDURE WERE, EXCELSIOR SL10, (B)(4) (LOT#UNKNOWN), V-TRACK MICROPLEX/TERUMO, (B)(4)(LOT#UNKNOWN), (B)(4) (LOT#UNKNOWN) (TOTAL 2), (B)(4) (LOT#UNKNOWN). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. CONCOMITANT DEVICES USED: ROADMASTER/GOODMAN, (B)(4) (LOT#UNKNOWN) AND CHIKAI/ASAHI INTEC WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE INDEX PROCEDURE WERE, EXCELSIOR SL10, (B)(4) (LOT#UNKNOWN), V-TRACK MICROPLEX/TERUMO, (B)(4) (LOT#UNKNOWN), (B)(4) (LOT#UNKNOWN) (TOTAL 2), (B)(4) (LOT#UNKNOWN). THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    AS REPORTED FROM (B)(6), THE INDEX PROCEDURE TOOK PLACE A YEAR AGO. THE PROCEDURE WAS COIL EMBOLISATION ASSISTED WITH VRDS ((B)(4)) OF LEFT PARASELLAR. ANGIOGRAPHY REVEALED VRD STENOSIS AROUND THE VRD DISTAL MARKERS. THE ADMINISTRATION OF CLOPIDOGREL SULFATE WAS DISCONTINUED. THE EVENT OUTCOME INDICATED AS "RECOVERED WITHOUT SEQUELAE". ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS HIGHLY PROBABLE. THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, DIABETES AND HYPOTHYROIDISM. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 3.9 MM, AND THE NECK TO SAC RATIO WAS 3.9 MM : 6.4 MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.3 MM AND DISTALLY WAS 4.3 MM. MRS BEFORE THE INDEX PROCEDURE WAS 0, AFTER THE PROCEDURE WAS 0, AND ON THREE MONTHS AFTER WAS 0. THE ACT WAS 123 SECONDS PRE ANTICOAGULATION AND 230 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 THE 1-YEAR FOLLOW-UP (ON (B)(6) 2012), THE ANEURYSM NECK WAS 3.9 MM, AND THE NECK TO SAC RATIO WAS 3.9 MM : 6.4 MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.3 MM AND DISTALLY WAS 4.3 MM. THE OCCLUSION RATE OF ANEURYSM WAS 100%. MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100 MG/DAY: , CLOPIDOGREL SULFATE 75 MG/DAY, CILOSTAZOL 100 MG/DAY, HEPARIN 10000 U, HEPARIN 5000 U WAS ADMINISTRATED INTRA-PROCEDURALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6655 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 02422610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention