BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4396341 · Received January 8, 2015

    Report

    Report Number
    1058196-2015-00005
    Event Type
    Death
    Date Received
    January 8, 2015
    Date of Event
    December 11, 2014
    Report Date
    December 19, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). COMPLAINT CONCLUSION: THE DEVICE REMAINED IMPLANTED IN THE PATIENT; THEREFORE, WAS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10353622. 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. ANEURYSM RUPTURE AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS WITH USE OF THE ENTERPRISE STENT OR THE PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT; HOWEVER, PATIENT FACTORS PUT THE PATIENT AT RISK FOR ANEURYSM RUPTURE (PREVIOUS COIL EMBOLIZATION, STENTING, AND HEMORRHAGE). THERE WAS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT EXPIRED DUE TO DELAYED RUPTURE OF A BASILAR ARTERY ANEURYSM AND SUBSEQUENT SUBARACHNOID HEMORRHAGE. HE HAD PRESENTED WITH REOCCURRENCE OF BASILAR TIP ANEURYSM AND UNDERWENT STENT ASSISTED COIL EMBOLIZATION WITH AN ENTERPRISE STENT (ENF453712 LOT # 10353622), FOLLOWED BY PLACEMENT OF ADDITIONAL STRYKER TARGET COILS. HE HAD A HISTORY OF SUBARACHNOID HEMORRHAGE IN 1990, AND PREVIOUSLY HAD COIL EMBOLIZATION TWICE WITH STRYKER TARGET COILS, WITH A NEUROFORM STENT PLACED FROM THE BASILAR ARTERY TO THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE PATIENT WAS ASYMPTOMATIC PRIOR TO AND IMMEDIATELY FOLLOWING THE CURRENT PROCEDURE. THE ENTERPRISE STENT WAS PLACED FROM THE BASILAR ARTERY TO THE LEFT POSTERIOR COMMUNICATING ARTERY, WITH GOOD VESSEL WALL APPOSITION AND NO EVIDENCE OF VESSEL DAMAGE OR MALFUNCTION. THE STENT AND COILS WERE PLACED WITHOUT INCIDENT. THE PATIENT WAS GIVEN 81MG ASPIRIN AND 81MG PLAVIX PRE-PROCEDURE AND HEPARIN WAS TITRATED TO ACT 100-250 INTRA-PROCEDURE WITH INTRA-PROCEDURE ACT RESULTS OF 212, 206, AND 243. IT WAS REPORTED THAT THE ANEURYSM DID NOT RUPTURE DURING OR IMMEDIATELY AFTER THE PROCEDURE. THE PATIENT AWOKE POST-PROCEDURE, AND EXPERIENCED VOMITING. A CT REVEALED SUBARACHNOID HEMORRHAGE OF THE BASILAR ARTERY, AND THE PATIENT EXPIRED APPROXIMATELY SIX HOURS AFTER THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS DELAYED RUPTURE OF THE BASILAR ARTERY ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16397 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC 10353622

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death STRYKER TARGET COILS, NEUROFORM STENT