BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER

    MDR report key: 9572216 · Received January 9, 2020

    Report

    Report Number
    2024168-2020-00532
    Event Type
    Death
    Date Received
    January 9, 2020
    Date of Event
    December 17, 2019
    Report Date
    February 11, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176340
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT INTERACTION WITH THE PREVIOUSLY IMPLANTED NON-ABBOTT STENTS RESULTED IN THE REPORTED FAILURE TO ADVANCE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE 2.5X15MM TREK RX AND ADDITIONAL GRAFTMASTER DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT PRESENTED WITH A RIGHT CORONARY ARTERY (RCA) CHRONIC TOTAL OCCLUSION, LEFT MAIN, LEFT CIRCUMFLEX, AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DISEASE. THE LAD HAD AN ULCERATED PROXIMAL PLAQUE, WAS EXTREMELY STENOTIC, AND THROMBOTIC OCCLUSION WAS OBSERVED. BALLOON DILATATION WAS PERFORMED USING A TREK RX WITHOUT NOTED ISSUES AND ANTIPLATELET MEDICATION PROVIDED. ASPIRATION THROMBECTOMY WAS PERFORMED AND MEDICATIONS PROVIDED. TWO NON-ABBOTT STENTS (ONYX) WERE IMPLANTED IN THE PROXIMAL LAD. BALLOON DILATATION WAS THEN PERFORMED USING A 2.5X15MM TREK RX CATHETER WHEN A MID-DISTAL LAD DISSECTION OCCURRED. AS TREATMENT, ADDITIONAL ANGIOPLASTY AND A NON-ABBOTT STENT (ONYX) WAS IMPLANTED. MEDICATIONS WERE ALSO PROVIDED. TIMI FLOW I WAS OBSERVED AND ADDITIONAL BALLOON DILATATION WAS PERFORMED USING A NON-ABBOTT DILATATION CATHETER (EUPHORA) WHEN A DISTAL LAD PERFORATION OCCURRED. MEDICATIONS WERE PROVIDED. THREE GRAFTMASTER STENT DELIVERY SYSTEMS (2.8X26MM, THEN A 2.8X16MM, AND ANOTHER 2.8X26MM) WERE UNABLE TO CROSS THE PREVIOUSLY IMPLANTED, NON-ABBOTT STENTS TO THE TREATMENT SITE. DURING THIS PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN, BECAME COMBATIVE, WAS INTUBATED, AND ANESTHESIA PROVIDED. THE PATIENT HAD CODED (CARDIOPULMONARY ARREST). ADDITIONAL DILATATION WAS PERFORMED USING MULTIPLE BALLOON CATHETERS. AN INTRA-AORTA BALLOON PUMP WAS PLACED, CONTINUOUS CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND MEDICATIONS ADMINISTERED. ADDITIONAL ASPIRATION THROMBECTOMY WAS PERFORMED. TIMI FLOW II WAS OBSERVED, AND THE PATIENTS CONDITION DECLINED. ONCE OFF THE IABP, THERE WAS NO UNDERLYING HEART RHYTHM AND NO BLOOD PRESSURE. THE PATIENT HAD EXPIRED THAT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34306 GRAFTMASTER CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012580-16 9032541 08717648176340

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death CORDIS 6F.| THREE ONYX STENTS.