BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASAHI FIELDER XT PTCA GUIDE WIRE

    MDR report key: 6080787 · Received November 4, 2016

    Report

    Report Number
    3003775027-2016-00198
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    October 13, 2016
    Report Date
    January 16, 2017
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K072431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: STENT: 2.25 X 28 MM, 2.25 X 28 MM AND 2.25 X 12 MM XIENCE ALPINE STENTS; 3.0 X 12 MM ABSORB SCAFFOLD. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE XIENCE ALPINE (2.25X12, (2) 2.25X28), ABSORB GT1 AND MINI TREK RX REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: DUE TO LACK OF INFORMATION HOW THE FIELDER GUIDE WIRE WAS USED AND HOW IT CONTRIBUTED TO PERFORATION OR DEATH, THE EXACT CAUSATION COULD NOT BE IDENTIFIED. ALTHOUGH DEVICE INVESTIGATION AND LOT HISTORY REVIEW OF THE SUBJECT FIELDER COULD NOT BE CONDUCTED, SINCE ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE MANUFACTURING PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT PRESENTED WITH SEVERE CHEST PAIN IN WHICH A 3.0 X 12 MM ABSORB SCAFFOLD, A 2.25 X 28 MM, 2.25 X 28 MM AND 2.25 X 12 MM XIENCE ALPINE STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION AND POST DILATATION WERE PERFORMED SUCCESSFULLY. THE PATIENT WAS GIVEN PLAVIX AND ASPIRIN. HOWEVER, APPROXIMATELY 7 - 8 HOURS LATER, THE PATIENT EXPERIENCED SEVERE CHEST PAIN AND CODED. THE PATIENT WAS SENT BACK TO THE CATH LAB FOR PERCUTANEOUS TRANSLUMINAL INTERVENTION (PTI). ANGIOGRAPHY REVEALED ACUTE THROMBOSIS OF THE STENTS AND SCAFFOLD. A FIELDER GUIDE WIRE WAS ADVANCED FOLLOWED BY A 2.0 X 15 MM TREK BALLOON CATHETER WHICH RESTORED A GOOD FLOW; HOWEVER, THE PATIENT CODED DUE TO A PERFORATION NOTED IN THE APEX. CHEST COMPRESSIONS WERE PERFORMED, BUT THE PATIENT DIED SUBSEQUENTLY. REPORTEDLY, CAUSE OF DEATH WAS TO NON-RESPONSE TO PLAVIX, SO IT WAS PROCEDURE RELATED. THERE WAS NO AUTOPSY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731168 ASAHI FIELDER XT PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death