BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1191894 · Received October 1, 2008

    Report

    Report Number
    1058196-2008-00234
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE DELIVERY WIRES WERE RETURNED COILED IN A PLASTIC BAG. BENT AND STRETCHED SECTIONS WERE FOUND ON THE PROXIMAL COIL OF THE PRODUCTS. THE STENTS AND INTRODUCERS WERE NOT RECEIVED. AS RECEIVED, THE SPECIMEN DEVICES DO NOT PRESENT ANY OBVIOUS INDICATIONS OF MFG DEFECTS OR ANOMALIES. THE SPECIMEN DEVICES APPEAR VISUALLY AND DIMENSIONALLY CORRECT. DIMENSIONALLY, THE THREE DELIVERY WIRES THAT WERE RETURNED MOST CLOSELY MATCHED A DELIVERY WIRE FOR AN ENTERPRISE 4.5X22 AND NOT A 4.5 BY 37. WHEN TESTED FOR PASSAGE WITHIN A MICROCATHETER, THE RETURNED DELIVERY WIRES PASSED FREELY THROUGH THE LENGTH OF THE CATHETER IN BOTH DIRECTIONS. BASED ON THE ANALYSIS OF THE RETURNED PRODUCT, WHICH FOUND ALL THREE DELIVERY WIRES TO BE CONSISTENT WITH DELIVERY WIRES FOR THE 4.5X22 ENTERPRISE STENT, FOLLOW-UP INVESTIGATION WAS CONDUCTED IN ORDER TO DETERMINE THE DISCREPANCY BETWEEN THIS FINDING AND THE REPORT THAT ONE OF THE STENTS WAS A 4.5 X 37 STENT. NO DEFINITIVE CLARIFICATION WAS OBTAINABLE. IT WAS REPORTED THAT IT IS POSSIBLE THAT THE THIRD DELIVERY WIRE WAS FROM THE FOURTH SENT WHICH WAS SUCCESSFULLY IMPLANTED. LAKE REGION REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MFG, INSPECTING AND PACKAGING OF LOT 01996292 AND LOT 01996810. THE RECORDS INDICATED THAT THE PRODUCTS WERE FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WERE DETERMINED TO BE ACCEPTABLE. BASED ON THE AVAILABLE INFO, NO DETERMINATION CAN BE MADE REGARDING THE CAUSE OF THE DAMAGE NOTED TO THE RETURNED DELIVERY WIRES, NOR CAN IT BE DETERMINED WHEN THE DAMAGE OCCURRED IN RELATIONSHIP TO THE REPORTED EVENT. THE RETURNED DELIVERY WIRES DO NOT PRESENT ANY OBVIOUS INDICATIONS OF DAMAGE OR ANOMALY THAT COULD BE CONTRIBUTORY TO THE REPORTED STENT INSERTION DIFFICULTIES. POSITIONING AND MAINTAINING THE POSITION OF THE INTRODUCER SLEEVE WITHIN THE HUB OF THE MICROCATHETER HAS BEEN DEMONSTRATED TO BE A CRUCIAL FACTOR IN THE PROPER PASSAGE OF THE ENTERPRISE STENT TO AND FROM THE MICROCATHETER. HOWEVER, WITHOUT THE RECEIPT OF THE ENTIRE ENTERPRISE VRD SYSTEM AND THE MICROCATHETER AND BASED ON THE AVAILABLE INFO, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED STENT INSERTION DIFFICULTIES. THIS PRODUCT IS SIMILAR TO US ENTERPRISE STENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS PRODUCT MALFUNCTION, WHICH IS ASSOCIATED WITH MFG REPORT # 1058196-2008-00235.

    Description of Event or Problem · 1

    THREE ENTERPRISE STENTS LOOSENED FROM THE DELIVERY WIRE WHEN THE PROXIMAL PART OF THE STENT PASSED AT THE TRANSITION POINT OF THE HUB INTO THE RAPID TRANSIT MICROCATHETER (MC). THE DELIVERY SYSTEMS, ALONG WITH THE STENTS, WERE REMOVED FROM THE MC WITHOUT POSITION OF THE MC BEING LOST. THE SAME MC AND ANOTHER ENTERPRISE STENT WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE ENTERPRISE DELIVERY WIRES WERE RETURNED FOR ANALYSIS, AND THE ANALYSIS SHOWED THE DELIVERY SYSTEMS WERE STRETCHED. THE TARGET SITE WAS THE MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT WITHOUT VESSEL TORTUOSITY. THE PRODUCTS WERE STORED ACCORDING TO (IFU) INSTRUCTION FOR USE GUIDELINES. THE PHYSICIAN INDICATED THAT THE EVENT OCCURRED INSIDE THE (MC) MICROCATHETER WHEN THE PROXIMAL PART OF THE STENT PASSED FROM THE HUB INTO THE MC AT THE TRANSITION FROM HUB INTO MC. OTHER THAN UTILIZING THE RAPID TRANSIT, ALL THE (IFU) INSTRUCTION FOR USE GUIDELINES WERE FOLLOWED WHEN UTILIZING THE PRODUCTS. THE MC WAS FLUSHED PRIOR AND DURING INSERTION, AND A CONSTANT AND A DEDICATED FLUSH WAS UTILIZED. THERE WAS NO COMPLAINT AGAINST THE MC, SINCE IT WORKED WHEN ANOTHER ENTERPRISE STENT WAS USED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 13358613

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BOSTON SYNCHRO-14| RAPID TRANSIT