BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 12953085 · Received December 7, 2021

    Report

    Report Number
    2024168-2021-11181
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176395
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 WAS REPORTED THAT THE GRAFTMASTER WAS DEPLOYED WITH A MAXIMUM PRESSURE OF 18 ATMOSPHERES (ATM). IT SHOULD BE NOTED IN THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, DOMESTIC, INSTRUCTIONS FOR USE (IFU) SPECIFIES THE RATED BURST PRESSURE (RBP) IS 16 ATM AND CLEARLY STATES NOT TO EXCEED THE RBP. IT IS UNKNOWN IF THE EXCEEDED RATED BURST PRESSURE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT 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 · 0

    (B)(4). THE STENT REMAINS IN PATIENT AND THE DELIVERY SYSTEM WAS DISCARDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE THREE ADDITIONAL GRAFTMASTER DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF THE LEFT MAIN (LM) ARTERY, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (CX) IN BETWEEN CARDIOPULMONARY RESUSCITATION (CPR). THE 3.5X16MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 18 ATMOSPHERES (ATMS) AND WAS DEPLOYED IN THE LM ARTERY. ANOTHER 2.8X19MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 18 ATMS AND WAS DEPLOYED IN THE SAME ARTERY. THE 3.5X19MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 16 ATMS AND WAS DEPLOYED IN THE LAD ARTERY. THE 2.8X16MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 16 ATMS AND WAS DEPLOYED IN THE CX ARTERY. UNFORTUNATELY, THE STENTS DID NOT SEAL THE PERFORATIONS DUE TO THE PERFORATIONS APPEARING TO BE VERY SIGNIFICANT, ANGIOGRAPHICALLY, AND BLOOD LEAK WAS MASSIVE. MORE THAN 2 HOURS INTO CARDIOPULMONARY RESUSCITATION (CPR), AFTER EXHAUSTING ALL POSSIBLE RESOURCES AND NOT GETTING ANY RESULTS, THE PATIENT DIED. THE EXTENT WAS SUCH, THAT THE LOCALIZED AREAS OF CONTRAST LEAK WERE HARD TO IDENTIFY, IT CERTAINLY INVOLVED THE LEFT MAIN CORONARY ARTERY AND IT'S BIFURCATION. EVEN AFTER PLACEMENT OF GRAFTMASTER STENTS, THE LEAK CONTINUED AND THE DIFFICULT ANATOMY (CALCIFICATION), PRESENCE OF BIFURCATION AND THE EXTENT OF PERFORATION, ALL PLAYED A ROLE IN THE INABILITY TO SEAL THE LEAK, WHILE THE CPR WAS ONGOING. MALAPPOSITION PROBABLY ALSO PLAYED A ROLE. IT WAS REPORTED THAT THE PATIENT'S HEALTH WAS DECLINING PRIOR TO USE OF THE GRAFTMASTER COVERED STENT AND DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK AND NO RESPONSE TO CPR AND THE USE OF THE GRAFTMASTER DID NOT CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF THE LEFT MAIN (LM) ARTERY, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (CX) IN BETWEEN CARDIOPULMONARY RESUSCITATION (CPR). THE 3.5X16MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 18 ATMOSPHERES (ATMS) AND WAS DEPLOYED IN THE LM ARTERY. ANOTHER 2.8X19MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 18 ATMOSPHERES (ATMS) AND WAS DEPLOYED IN THE SAME ARTERY. THE 3.5X19MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 16 ATMOSPHERES (ATMS) AND WAS DEPLOYED IN THE LAD ARTERY. THE 2.8X16MM GRAFTMASTER COVERED STENT WAS INFLATED ONCE WITH A PRESSURE OF 16 ATMOSPHERES (ATMS) AND WAS DEPLOYED IN THE CX ARTERY. UNFORTUNATELY, THE STENTS DID NOT SEAL THE PERFORATIONS DUE TO THE PERFORATIONS APPEARING TO BE VERY SIGNIFICANT, ANGIOGRAPHICALLY, AND BLOOD LEAK WAS MASSIVE. MORE THAN 2 HOURS INTO CARDIOPULMONARY RESUSCITATION (CPR), AFTER EXHAUSTING ALL POSSIBLE RESOURCES AND NOT GETTING ANY RESULTS, THE PATIENT DIED. THE EXTENT WAS SUCH, THAT THE LOCALIZED AREAS OF CONTRAST LEAK WERE HARD TO IDENTIFY, IT CERTAINLY INVOLVED THE LEFT MAIN CORONARY ARTERY AND IT'S BIFURCATION. EVEN AFTER PLACEMENT OF GRAFTMASTER STENTS, THE LEAK CONTINUED AND THE DIFFICULT ANATOMY (CALCIFICATION), PRESENCE OF BIFURCATION AND THE EXTENT OF PERFORATION, ALL PLAYED A ROLE IN THE INABILITY TO SEAL THE LEAK, WHILE THE CPR WAS ONGOING. MALAPPOSITION PROBABLY ALSO PLAYED A ROLE. IT WAS REPORTED THAT THE PATIENT'S HEALTH WAS DECLINING PRIOR TO USE OF THE GRAFTMASTER COVERED STENT AND DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK AND NO RESPONSE TO CPR AND THE USE OF THE GRAFTMASTER DID NOT CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844162 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012581-16 0012241 08717648176395

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Life Threatening| R