BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 8065156 · Received November 13, 2018

    Report

    Report Number
    2024168-2018-08731
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 17, 2018
    Report Date
    January 11, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IN THIS CASE A PERFORATION OCCURRED IN THE MID LAD TREATMENT. THREE GRAFTMASTER (GM) WERE USED FOR THIS PROCEDURE. FIRST GM FAILED TO CROSS THE LESION AND WAS UNDEPLOYED. THE 2ND GM WAS DEPLOYED AND PARTIALLY SEALED THE PERFORATION. THE 3RD GM WAS DEPLOYED BUT DID NOT SEAL THE PERFORATION. THE PATIENT EXPERIENCED CARDIAC ARREST AND HEROIC MEASURES WERE INITIATED. A TREK BALLOON WAS EVENTUALLY USED TO TAMPONADE THE VESSEL. PATIENT EXPIRED IN THE CATH LAB. PATIENT WAS HIGH RISK CANDIDATE FOR CABG PER PHYSICIAN'S NOTES. PATIENT HAD SEVERE 3 VESSEL DISEASE; LAD, RCA, CX. PROXIMAL RCA 100%, DISTAL RCA 90% STENOSED. 55% EJECTION. PATIENT IS A VERY ELDERLY ON WALKER, WITH LIMITED MOBILITY, REHAB AFTER STROKE, AFIB, CENTRAL HYPERTENSION, TIA, ON COUMADIN NIGHTLY, HYPERTENSION. THERE IS NO EVIDENCE OF A PRODUCT ISSUE IN THIS CASE AND THE CAUSE OF DEATH IS LIKELY DUE TO THE COMPLICATIONS OF THE VESSEL PERFORATION. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PERFORATION; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL TWO GRAFTMASTER DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, IT WAS CONFIRMED THAT THE GRAFTMASTER THAT FAILED TO CROSS WAS THE FIRST GRAFTMASTER THAT WAS USED (2.8 X 26 MM, LOT NUMBER 7051841). THE SECOND TWO GRAFTMASTERS 2.8 X 16 MM WERE USED NEXT. THEY ARE THE SAME LOT NUMBER, SO IT IS UNABLE TO BE DETERMINED WHICH ONE WAS DEPLOYED FIRST. THE 2.8 X 16 MM COVERED STENTS WERE DEPLOYED AT 1615 AND 1621. IT WAS CONFIRMED THE PATIENT ARRESTED ON TABLE; VENTRICULAR FIBRILLATION; SHOCKED TWO TIMES; INTUBATED, CARDIOPULMONARY RESUSCITATION STARTED AT 1635, SMALL AREA OF EFFUSION ON STAT ECHOCARDIOGRAM; PATIENT WAS INTUBATED. PATIENT DEVELOPED BRADYCARDIA. GAVE PROTAMINE AT 1645. TIME OF DEATH WAS 1710. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED THROUGH THE EMERGENCY DEPARTMENT WITH COMPLAINT OF CHEST PAIN AND MEDICATION WAS GIVEN. THE PATIENT WAS FOUND TO BE IN CARDIAC ARREST WITH UNDERLYING CARDIAC CONDITIONS. THE PATIENT WAS A HIGH-RISK CANDIDATE FOR CORONARY ARTERY BYPASS GRAFT. PATIENT HAD PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2018 AND WAS HELD IN THE HOSPITAL, MOST LIKELY DUE TO THEIR INTERNATIONAL NORMALIZED RATIO (INR) NEEDING TO COME DOWN DUE TO ATRIAL FIBRILLATION. THE PATIENT HAD SEVERE 3-VESSEL DISEASE. A GRAFTMASTER 2.8 X 16 MM WAS DEPLOYED BUT ONLY PARTIALLY SEALED THE PERFORATION. THEN, A GRAFTMASTER 2.8 X 26 MM WAS ADVANCED BUT FAILED TO CROSS; THE STENT WOULD NOT MAKE A SHARP TURN IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AND WAS TAKEN OUT UNDEPLOYED. A THIRD GRAFTMASTER 2.8 X 16 MM WAS DEPLOYED, BUT DID NOT COMPLETELY SEAL THE PERFORATION. A TREK BALLOON WAS THEN USED TO TAMPONADE THE VESSEL. THE PATIENT WAS AWAKE DURING PCI BUT SUBSEQUENTLY DIED IN THE CATH LAB AFTER RECEIVING COMFORT MEASURES POST-PROCEDURE. THE CAUSE OF DEATH IS NOT AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903184 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 7020841

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention