BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER

    MDR report key: 19873698 · Received July 31, 2024

    Report

    Report Number
    2024168-2024-09054
    Event Type
    Death
    Date Received
    July 31, 2024
    Date of Event
    July 9, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAF
    UDI-DI
    08717648186998
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED ACTIVATION FAILURE COULD NOT BE CONFIRMED DUE TO THE CONDITION THE DEVICE WAS RECEIVED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. A MEDICAL REVIEW WAS PERFORMED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE REVIEWER CONCLUDED THAT A 63-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PRESENTED WITH A HEAVILY CALCIFIED LESION IN THE RIGHT DOMINANT CORONARY ARTERY (RCA). THE ETIOLOGY AND PRECISE LOCATION OF THE PERFORATION REMAIN UNDETERMINED. HOWEVER, THE RETURNED CONDITION OF THE GRAFTMASTER STENT DELIVERY SYSTEM INDICATED SIGNIFICANT DIFFICULTY IN ADVANCING THE DEVICE TO THE PERFORATION SITE. THIS 95% STENOSIS WAS LIKELY BEING PREPARED FOR STENTING WHEN AN UNIDENTIFIED DEVICE CAUSED A PERFORATION. THE SEVERELY STENOSED VESSEL PRESENTED SUBSTANTIAL RESISTANCE TO THE ADVANCEMENT OF THE GRAFTMASTER, RESULTING IN KINKS, BENDS, AND CORKSCREWING OF THE INNER AND OUTER MEMBRANES AND THE SUPPORT WIRE. THIS ALSO LED TO THE SUPPORT WIRE WITHIN THE STENT DELIVERY SYSTEM BREAKING AND PROTRUDING FROM THE OUTER MEMBRANE. THE KINKS IN THE HYPOTUBE RENDERED STENT INFLATION IMPOSSIBLE, AND EVEN IF INFLATION HAD BEEN ACHIEVED, BALLOON DEFLATION WOULD HAVE BEEN UNLIKELY DUE TO THE HYPOTUBE¿S COMPROMISED INTEGRITY. BASED ON THIS NEW INFORMATION, IT CAN BE CONCLUSIVELY STATED THAT THE EXTENSIVE DAMAGE TO THE GRAFTMASTER STENT DELIVERY SYSTEM WAS DUE TO THE ENCOUNTERED RESISTANCE AND THE SIGNIFICANT FORCE APPLIED DURING ATTEMPTS TO ADVANCE IT TO THE PERFORATION SITE. CONSEQUENTLY, THE GRAFTMASTER STENT INDIRECTLY CONTRIBUTED TO THE PATIENT¿S DEATH. HOWEVER, THE DIRECT CAUSES OF DEATH WERE THE PERFORATION AND SUBSEQUENT CARDIAC TAMPONADE. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AS IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY CALCIFIED AND 95% STENOSED LESION DURING ADVANCEMENT CAUSING THE NOTED SEVERE DAMAGE TO THE DELIVERY SYSTEM SHAFT. BASED ON THE INFORMATION RECEIVED, MEDICAL REVIEW BY AN ABBOTT VASCULAR CLINICAL SPECIALIST AND ANALYSIS OF THE RETURNED DEVICE, THE INVESTIGATION DETERMINED THAT THE REPORTED ACTIVATION FAILURE APPEARS TO BE RELATED OPERATIONAL CONTEXT. IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY CALCIFIED AND 95% STENOSED LESION DURING ADVANCEMENT CAUSING THE NOTED SEVERE DAMAGE TO THE DELIVERY SYSTEM SHAFT. BASED ON THE REPORTED INFORMATION AND THE CONDITION OF THE RETURNED DEVICE, IT CAN BE CONCLUSIVELY STATED THAT THE EXTENSIVE DAMAGE TO THE GRAFTMASTER STENT DELIVERY SYSTEM WAS DUE TO THE ENCOUNTERED RESISTANCE AND THE SIGNIFICANT FORCE APPLIED DURING ATTEMPTS TO ADVANCE IT TO THE PERFORATION SITE. CONSEQUENTLY, THE GRAFTMASTER STENT INDIRECTLY CONTRIBUTED TO THE PATIENT¿S DEATH. HOWEVER, THE DIRECT CAUSES OF DEATH WERE THE PERFORATION AND SUBSEQUENT CARDIAC TAMPONADE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CORONARY PERFORATION IN THE RIGHT CORONARY ARTERY WITH SEVERE CALCIFICATION AND 95% STENOSIS. THE 3.5X19 MM GRAFTMASTER COVERED STENT FAILED TO DEPLOY AS THE BALLOON DID NOT OPEN AT ALL. THEREFORE, SURGERY WAS PERFORMED TO TREAT THE PERFORATION. CARDIAC TAMPONADE OCCURRED AS WELL AS PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT ULTIMATELY EXPIRED DUE TO CARDIAC TAMPONADE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885158 GRAFTMASTER CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR INC. 1012818-19 3032441 08717648186998

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death