BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5066597 · Received September 9, 2015

    Report

    Report Number
    1058196-2015-00176
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    July 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO STERILE LOT NUMBERS WERE REPORTED, THUS NO DHR COULD BE PERFORMED. THROMBO-EMBOLISM, OCCLUSION OF PARENT AND/OR SIDE BRANCHES OF TARGET LESION AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH PLACEMENT OF INTRACRANIAL STENTS FOR ANEURYSM COIL EMBOLIZATION PROCEDURES. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET SITE, INTRAPROCEDURAL ISSUES, SPECIFICALLY THE VASOSPASM, AND MEDICATION REGIMEN FACTORS, I.E. THE INABILITY TO ADMINISTER THROMBOLYTICS, MAY HAVE ALL CONTRIBUTED TO THE UNFORTUNATE EVENTS. UDI: UNKNOWN PART NUMBER, PRODUCT WAS IMPLANTED AND NOT AVAILABLE FOR RETURN, UDI UNAVAILABLE. THIS REPORT IS RELATED TO MFR. REPORT # 1058196-2015-00177.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO CORRECT THE EVENT TYPE TO ¿DEATH¿. IT WAS PREVIOUSLY ENTERED AS "SERIOUS INJURY". THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1058196-2015-00176 & 1058196-2015-00177.

    Description of Event or Problem · 1

    THE NURSE FROM THE HOSPITAL REPORTED THAT THE PATIENT HAD A THROMBOEMBOLIC OCCLUSION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BRANCH RESULTING IN DEATH FOLLOWING STENT-ASSISTED COIL EMBOLIZATION OF A PREVIOUSLY RUPTURED RECURRING SUPRACLINOID RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. AN ENTERPRISE HDE STENT (CATALOG AND LOT UNKNOWN) WAS USED DURING THE PROCEDURE. THE PATIENT WAS INITIALLY ADMITTED TO THE HOSPITAL PRESENTING WITH HEADACHE, VOMITING AND POSSIBLE SEIZURE. A CAT SCAN OF THE HEAD AT THAT TIME SHOWED DIFFUSE BILATERAL SUBARACHNOID HEMORRHAGE WITH EXTENSION INTO THE UPPER CERVICAL SPINE. AT THAT TIME THE PATIENT UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RUPTURED SUPRACLINOID RIGHT ICA ANEURYSM WITH AN ENTERPRISE HDE STENT (DETAILS UNKNOWN) AND 8 COMPETITOR COILS. TWO WEEKS LATER, THERE WAS A RECURRENCE OF THE ANEURYSM MEASURING 1.5 MM X 2 MM. AT THIS TIME VERAPAMIL WAS ADMINISTERED FOR TREATMENT OF GLOBAL CEREBRAL VASOSPASMS AFTER WHICH RESIDUAL VASOSPASMS WERE MILD TO MODERATE IN INTENSITY. STENT-ASSISTED COIL EMBOLIZATION WAS THEN PERFORMED USING A SECOND ENTERPRISE HDE STENT AT THE SAME TARGET SITE TO TREAT THE RECURRING ANEURYSM. FOLLOWING PLACEMENT OF THE SECOND INTRACRANIAL STENT, IT WAS NOTED THAT THERE WAS A THROMBOEMBOLIC OCCLUSION IN A LARGE RIGHT M2 BRANCH IN THE MCA. SINCE IT WAS DIFFICULT TO NAVIGATE A MICROWIRE THROUGH THE STENT COMPLEX TO RETRIEVE THE THROMBUS, INTEGRILIN WAS ADMINISTERED INSTEAD. FOLLOW-UP ANGIOGRAPHY DEMONSTRATED PARTIAL RECANALIZATION OF THE THROMBUS WITH PERSISTENT SUBOCCLUSIVE THROMBUS BUT WITH IMPROVED ANTEGRADE FLOW INTO THE RIGHT MCA TERRITORY. UNFORTUNATELY, THE PATIENT HAD PROGRESSION OF RIGHT MCA INFARCT SECONDARY TO THE THROMBOEMBOLIC OCCLUSION TWO DAYS AFTER THE EMBOLIZATION OF THE RECURRING ANEURYSM. INTEGRILIN WAS ADMINISTERED AGAIN HOWEVER ADDITIONAL THROMBOLYTICS WERE NOT ADMINISTERED DUE TO SIGNIFICANT POTENTIAL RISK OF INTRACRANIAL HEMORRHAGE. THE PATIENT DETERIORATED AND IT WAS DECIDED BY THE FAMILY TO DESIGNATE THE PATIENT A DO NOT RESUSCITATE LEVEL 3 PATIENT AND THE PATIENT EXPIRED FOUR DAYS FROM THE SECOND PROCEDURE. A MEMORANDUM FROM THE INSTITUTIONAL REVIEW BOARD OFFICE STATED THAT THE THROMBOEMBOLIC OCCLUSION WAS NOT DUE TO A STENT MALFORMATION. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594529 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R| S