BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER

    MDR report key: 19704272 · Received July 9, 2024

    Report

    Report Number
    2024168-2024-08070
    Event Type
    Death
    Date Received
    July 9, 2024
    Date of Event
    December 28, 2023
    Report Date
    August 20, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAF
    UDI-DI
    08717648187001
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO SIMILAR COMPLAINTS FROM THIS LOT. IT WAS REPORTED THAT A 3.5X26MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 6 ATMOSPHERES (ATM) FOLLOWED BY POST DILATATION WITH A 3X10MM NC BALLOON AT 8 ATM. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE (IFU), SPECIFIES: DEPLOY THE STENT GRAFT SLOWLY BY PRESSURIZING THE DELIVERY SYSTEM IN 2 ATM INCREMENTS EVERY 5 SECONDS UNTIL THE STENT IS COMPLETELY EXPANDED. FULLY EXPAND THE STENT GRAFT BY INFLATING TO NOMINAL PRESSURE AT A MINIMUM. PER THE GRAFTMASTER PRODUCT LABEL, NOMINAL PRESSURE IS SPECIFIED AT 15 ATMOSPHERES, RATED BURST PRESSURE (RBP) IS SPECIFIED AT 16 ATMOSPHERES. IT IS LIKELY THE IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE TO SEAL. PATIENT-DEVICE INCOMPATIBILITY (FAILURE TO SEAL THE PERFORATION) MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PRODUCT SIZE SELECTION, DEPLOYMENT TECHNIQUE, INTERFERENCE FROM PREVIOUSLY DEPLOYED DEVICES, OR GROWTH OF PERFORATION DURING DEPLOYMENT. IN THIS CASE, IT IS LIKELY THE REPORTED PATIENT-DEVICE INCOMPATIBILITY (FAILURE TO SEAL)/STENT GRAFT LEAK WAS DUE TO THE IFU DEVIATION, AS THE STENT WAS REPORTEDLY NOT INFLATED TO NOMINAL PRESSURE WHEN DEPLOYED. A CINE WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST: CINE IMAGES SHOWED THERE WAS A LESION DISTAL TO THE STENT. SEVERAL PRE-DILATATIONS WITHIN THE STENT WERE PERFORMED AND PRE-DILATATION WITHIN THE DISTAL LESION WAS PERFORMED. A STENT WAS DEPLOYED IN THE DISTAL LESION AND SEVERAL POST-DILATIONS WITH A LONG BALLOON WITHIN BOTH STENTS AND THEN A SMALLER BALLOON WITHIN THE DISTAL STENT WERE PERFORMED. POST-DILATATION IMAGING REVEALED A SMALL PERFORATION WITHIN THE DISTAL STENT. A STENT, MOST LIKELY THE 2.5 X 26 GRAFTMASTER STENT, WAS ADVANCED TO THE DISTAL LESION BUT WAS NOT DEPLOYED. IT WAS PULLED BACK INTO THE MID-LAD STENT AND DEPLOYED WITHIN THAT STENT WITH SERIAL SEQUENTIAL BALLOON INFLATIONS, WITH A FINAL INFLATION WITHIN THE DISTAL STENT. POST-DEPLOYMENT IMAGING SHOWS THE PERFORATION INCREASED IN SIZE. ADDITIONAL IMAGING SHOWS AN ADDITIONAL STENT, MOST LIKELY THE 3.5 X 26 GRAFTMASTER STENT, ADVANCED TO THE LOCATION OF THE PERFORATION IN THE DISTAL STENT. THE IMAGING ALSO SHOWS THE PATIENT IS EXPERIENCING SEVERE BRADYCARDIA AS THIS STENT IS SLOWLY DEPLOYED. CARDIOPULMONARY RESUSCITATION (CPR) IS STARTED BEFORE A POST-DILATATION BALLOON IS ADVANCED TO THE DISTAL STENT AND CPR IS RESUMED. SEVERAL POST-DILATION BALLOON INFLATIONS ARE PERFORMED THROUGHOUT THE ENTIRE LENGTH OF BOTH GRAFTMASTER STENTS. A CATHETER IS SEEN IN THE LOWER RIGHT SIDE OF THE CHEST, MOST LIKELY A PERICARDIOCENTESIS CATHETER. SEVERAL ADDITIONAL POST-DILATATION INFLATIONS ARE SEEN IN THE DISTAL GRAFTMASTER STENT AND THE DISTAL LAD. FOLLOW-UP IMAGING SHOWS THAT THE PERFORATION WAS NOT COMPLETELY SEALED AND A LARGE AMOUNT OF CONTRAST IS FILLING THE PERICARDIUM. THE PERICARDIOCENTESIS CATHETER WAS REPOSITIONED AND A PROLONGED BALLOON TAMPONADE WITHIN THE DISTAL GRAFTMASTER STENT AND THE DISTAL LAD WAS PERFORMED. LATER IMAGING SHOWS THAT THE PERFUSION IS CLOSED, HOWEVER, THIS APPEARS TO BE DUE TO SLOW FLOW IN THE DISTAL ARTERY THAT EVENTUALLY OCCLUDES THE DISTAL LAD. AN IMAGE OF THE REPORTED INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT PART OF THE PROVIDED IMAGES AND THEREFORE CANNOT BE CONFIRMED. A MEDICAL REVIEW WAS PERFORMED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST: DUE TO THE INFORMATION PROVIDED, IT CAN BE DEFINITIVELY STATED THAT THE GRAFTMASTER STENT WAS NOT THE CAUSE OR A CONTRIBUTOR TO THE PATIENT¿S DEATH. THE FORMAL CAUSE OF DEATH WAS NOT REPORTED. HOWEVER, THIS PATIENT EXPIRED, MOST LIKELY DUE TO THE CASCADE OF EVENTS THAT TRANSPIRED DUE TO THE PERFORATION IN THE LAD. THE 3.5 X 26 GRAFTMASTER WAS REPORTED AS BEING DEPLOYED AT 6ATM AND IS AN IFU DEVIATION. DUE TO THIS INFORMATION, THE IFU AND COMPLIANCE CHART WERE NOT FOLLOWED, ALLOWING THIS 3.5 X 26 GRAFTMASTER TO BE UNDERINFLATED AND UNDER-EXPANDED. AT THIS INFLATION OF 6 ATM, THE GRAFTMASTER IS NOT FULLY EXPANDED AND, THEREFORE, NOT APPOSED TO THE VESSEL WALL, LEAVING THE PERFORATION UNSEALED. IT CAN BE DEFINITIVELY STATED THAT THE GRAFTMASTER STENT WAS NOT THE CAUSE OR A CONTRIBUTOR TO THE PATIENT¿S DEATH. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT UNEXPECTED MEDICAL INTERVENTION AND SURGICAL INTERVENTION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE REPORTED PATIENT EFFECTS OF CARDIAC TAMPONADE, HYPOTENSION, CARDIAC ARREST AND DEATH, AS LISTED IN THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM IFU, ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN THE DESCRIPTION OF INCIDENT IS FILED UNDER A SEPARATE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT PRESENTED WITH CHEST PAIN. IMAGING REVEALED A TANDEM 90% IN STENT RE-STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH CALCIFICATION. A 2.75X48MM NON-ABBOTT STENT WAS DEPLOYED AND A PERFORATION WAS NOTED. THE 2.5X26MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE DEPLOYED AT THE PERFORATION; HOWEVER, THE STENT BALLOON WOULD NOT INFLATE. AN ATTEMPT WAS MADE TO REMOVE THE GRAFMASTER AND DURING REMOVAL, THE STENT DISLODGED IN THE MIDDLE OF THE PREVIOUSLY IMPLANTED STENT. THE DISLODGED STENT WAS RETRIEVED WITH A MICROCATHETER COVERED WITH A FLUSH 0.014 WHISPER GUIDE WIRE WITH DIFFICULTY. THE IMPLANTED STENT WAS DEPLOYED WITH SERIAL DILATATION WITH AN 1.5MM, 2.5MM AND 3.0MM BALLOONS; HOWEVER, TAMPONADE WORSENED. THE PERICARDIUM WAS DRAINED WITH A 6F SHEATH, BUT THE PATIENT WENT INTO CARDIAC ARREST. CPR WAS PERFORMED TO REVIVE THE PATIENT. THE PATIENT WAS INTUBATED AND VENTILATED, THEN A 3.5X26MM GRAFTMASTER COVER STENT WAS DEPLOYED AT 6 ATMOSPHERES (ATM) FOLLOWED BY POST DILATATION WITH A 3X10MM NC BALLOON AT 8 ATM. IMAGING SHOWED CONTINUED BLEEDING AND PERFORATION. BALLOON TAMPONADE WAS PERFORMED AND ECHO SHOWED NO TAMPONADE, HOWEVER, HYPOKINESIA WAS NOTED IN THE LAD. AN INTRO AORTIC BALLOON PUMP (IABP) WAS PLACED. ON (B)(6) 2023, THE PATIENT WENT UNDER SURGERY TO DRAIN AND CLOSE THE PERFORATION AND TO GRAFT DISTAL LAD WITH CARDIAC TAMPONADE AND REPAIR; HOWEVER, THE PATIENT WENT INTO BRADYCARDIA WITH HYPOTENSION AND CPR WAS STARTED FOLLOWED BY AN INJECTION OF ADRENALINE. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED WITH CARDIAC TAMPONADE EXPLORATION, RIGHT VENTRICLE REPAIR AND MULTIPLE BLOOD TRANSFUSIONS. ON (B)(6) 2023 PLEURAL EFFUSION WAS NOTED. A HYPOXIC ENCEPHALOPATHY NEUROLOGY REFERENCE WAS TAKEN AND A BRAIN MRI WAS ADVISED. THE PATIENT WAS ON HIGH INOTROPIC SUPPORT AND ON A MECHANICAL VENTILATOR. ON (B)(6) 2023 CCRT WAS STARTED AND THE PATIENT WAS MANAGED WITH ANTIPLATELETS, IV ANTIBIOTICS AND MEDICATION. THE PATIENT HAD MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA, DIRECT CURRENT SHOCK AND ANTIARRHYTHMIC DRUG WAS GIVEN. ON (B)(6) 2024 THE PATIENT WENT INTO CARDIAC ARREST WITH SEVERE BRADYCARDIA. ALTHOUGH, CPR WAS STARTED THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392023 GRAFTMASTER CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR INC. 1012818-26 2021641 08717648187001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death 1.5MM BALLOON| 14 WHISPER GUIDE WIRE| 2.5MM BALLOON| 2.5X26MM GRAFTMASTER STENT| 2.75X48 SYNERGY STENT| 3.0MM BALLOON| 6F SHEATH