BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6060615 · Received October 27, 2016

    Report

    Report Number
    1226348-2016-00156
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    June 15, 2016
    Report Date
    October 17, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 1226348-2016-00156. UDI UNAVAILABLE; UNKNOWN PART NUMBER AND LOT NUMBER. MANUFACTURING DATE UNAVAILABLE, LOT NUMBER UNKNOWN. THE DEVICE WAS NOT RETURNED AND NEITHER A PRODUCT CATALOGUE NOR LOT NUMBER WAS PROVIDED, THEREFORE, NO DHR OR ANALYSIS COULD BE PERFORMED. INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD DEVICE AND IS LISTED IN THE IFU AS SUCH. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT TARGET LESION CHARACTERISTICS, MEDICATION REGIMEN FACTORS AND PREVIOUSLY PLACED DEVICES MAY HAVE ALL CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT ON (B)(6) 2016 PATIENT DEVELOPED BRAIN INFARCT AT THE BASILAR TIP POST STENTING PROCEDURE. PATIENT UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM ON (B)(6) 2013 USING UNKNOWN COILS AND A NEUROFORM STENT (COMPETITOR'S DEVICE). INFORMATION OF OTHER DEVICES USED DURING THE SURGERY IS NOT AVAILABLE. PATIENT WAS A (B)(6) -YEAR OLD MALE (AT (B)(6) 2013) WITH MEDICAL HISTORY OF HIGH BLOOD PRESSURE. DURING FOLLOW-UP ON (B)(6) 2016 RE-EXPANSION AND RE-CANALIZATION OF THE ANEURYSM WAS CONFIRMED. ON (B)(6) 2016 ENTERPRISE STENT (CATALOG#/LOT# UNKNOWN) WAS PLACED FROM CONTRALATERAL POSTERIOR CEREBRAL ARTERY AS A Y-STENT WITH A NEUROFORM STENT; ADDITIONAL COIL EMBOLIZATION WAS ALSO PERFORMED. PATIENT DEVELOPED BRAIN INFARCT ON (B)(6) 2016, AS PER THE PHYSICIAN THE PATIENT HAD ISCHEMIC SYMPTOMS. REHABILITATION WAS PERFORMED AND MEDICATION WAS PRESCRIBED; IT WAS REPORTED THAT THE PATIENT RECOVERED ON (B)(6) 2016. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713303 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention NEUROFORM STENTUNKNOWN COIL (QUANTITY UNKNOWN)