BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1820312 · Received August 30, 2010

    Report

    Report Number
    1016427-2010-00095
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    May 19, 2010
    Report Date
    October 4, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY INDICATING TECHNICAL DIFFICULTIES WITH THE ANGIOGUARD DURING STENTING OF A 95% SEVERELY CALCIFIED TORTUOUS LEFT INTERNAL CAROTID ARTERY OSTIAL STENOSIS. IT WAS REPORTED THAT THE DELIVERY OF THE 7MM ANGIOGUARD (701814RMC/71109509) WAS ATTEMPTED BUT THE DISTAL TIP OF THE DELIVERY SYSTEM BECAME WEDGED ON THE DISTAL END OF THE IMPLANTED PRECISE STENT. THE DECISION WAS MADE TO REMOVE THE ANGIOGUARD. THERE WAS SOME REMOVAL DIFFICULTY BUT IT WAS ABLE TO BE REMOVED AFTER SOME MANEUVERING. ANOTHER ANGIOGUARD, A 6MM BASKET (601814RMC/70110509) WAS THEN USED, BUT IT FAILED TO TRACT TO THE TARGET LESION. AN EV3-SPIDER 7MM PROTECTION DEVICE WAS THEN USED. ONCE THIS WAS IN PLACE, THE PRECISE STENT WAS SUCCESSFULLY POST DILATED. THE TARGET LESION WAS A 95% SEVERELY CALCIFIED AND TORTUOUS. IT WAS INDICATED THAT A 9X30 PRECISE PRO RX DEPLOYED AT THE TARGET LESION WITH NO MALFUNCTIONS OR ASSOCIATED MAJOR ADVERSE EVENTS. WITH INVESTIGATIVE EFFORTS NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PLACEMENT OF THE PRECISE STENT PRIOR TO THE ANGIOGUARD OR CONFIRMATION OF THE SEQUENCE OF EVENTS. THE ANGIOGUARD SYSTEM IS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 02414299 WHICH CORRESPONDS TO CORDIS ANGIOGUARD LOT 71109509. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE IFU OUTLINES PLACEMENT OF THE ANGIOGUARD EMBOLIC PROTECTION DEVICE PRIOR TO IMPLANTATION OF THE STENT. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. ALTHOUGH WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE RELATIONSHIP BETWEEN THE WITHDRAWAL DIFFICULTY AND THE PRODUCT ITSELF CANNOT BE CONCLUSIVELY DETERMINED. FACTORS SUCH AS THE TORTUOUS HEAVILY CALCIFIED LESION AND TRACKING THROUGH AN EXISTING STENT APPEAR TO HAVE CONTRIBUTED TO THE EVENT. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS SEVERELY CALCIFIED AND TORTUOUS. THE EMAIL RECEIVED FOR THE (B)(4) STUDY INDICATED THAT A PRECISE STENT HAD BEEN SUCCESSFULLY IMPLANTED AT THE TARGET LESION. AN ANGIOGUARD DEVICE WAS ATTEMPTED BUT THE DISTAL TIP OF THE DELIVERY SYSTEM BECAME WEDGED ON THE DISTAL END OF THE IMPLANTED PRECISE STENT. THE PHYSICIAN DECIDED TO REMOVE THE ANGIOGUARD. THERE WAS SOME REMOVAL DIFFICULTY BUT THE PHYSICIAN WAS ABLE TO REMOVE IT AFTER SOME MANEUVERING. ANOTHER ANGIOGUARD WAS THEN USED BUT FAILED TO TRACK TO THE TARGET LESION. THE PHYSICIAN THEN USED A EV3-SPIDER 7MM PROTECTION DEVICE. ONCE IN PLACE, THE PRECISE STENT WAS SUCCESSFULLY POST-DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71109509

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR PRECISE STENT