BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2151792 · Received July 6, 2011

    Report

    Report Number
    2024168-2011-04780
    Event Type
    Death
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PATIENT WAS DETERMINED NOT TO BE A VIABLE CANDIDATE FOR SURGICAL INTERVENTION BECAUSE OF HER PREVIOUS BYPASS PROCEDURE. AFTER DISCUSSION WITH THE FAMILY MEMBERS AND A SIGNIFICANT AMOUNT OF CPR ATTEMPTS, IT WAS FELT THAT THE PATIENTS NEUROLOGICAL STATUS WOULD NOT HAVE BEEN MAINTAINED. PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL, GUIDE CATH: 7 FR XP 3.5, STENT: GRAFTMASTER (3.5X26). THE BALANCE MIDDLEWEIGHT GUIDE WIRE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. ADDITIONALLY, THE 3.5 X 26 JOSTENT IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. BRADYCARDIA (A FORM OF ARRHYTHMIA), HYPOTENSION, ISCHEMIA, AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICES CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION ON THE RIGHT CORONARY ARTERY ON (B)(6) 2011 DURING WHICH NON-ABBOTT STENTS WERE DEPLOYED. ON (B)(6) 2011, THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THE LEFT CIRCUMFLEX ARTERY (LCX), AND THE LEFT MAIN (LM) CORONARY ARTERY. AFTER PREDILATATION AND PLACEMENT OF FIVE NON-ABBOTT STENTS, A BMW UNIVERSAL GUIDE WIRE WAS ADVANCED THROUGH THE STENT STRUTS OF THE LAST DEPLOYED NON-ABBOTT STENT, IN THE OSTIUM OF THE LCX. AT THAT TIME, THE PATIENT DEVELOPED WHAT APPEARED TO BE A PERFORATION OF THE LAD. SHE MAINTAINED HEMODYNAMIC STABILITY AT THAT POINT OF TIME, AT WHICH TIME, A 3.5 X 26 COVERED STENT WAS INSERTED OVER THE WIRE AND DEPLOYED IN THE PROXIMAL LAD. THE PATIENT CONTINUED TO APPEAR TO HAVE SOME ASPECT OF PERFORATION IN THE LM; THEREFORE, A 4.0 X 16 COVERED STENT WAS INSERTED IN THE LM, EXTENDING OUT INTO THE AORTA. THERE WERE NO OTHER COVERED STENTS AVAILABLE IN SHORTER LENGTH; THEREFORE, THE DECISION WAS MADE TO PROCEED DUE TO THE PATIENT POSSIBLY BEING IN EXTREMES. AFTER DEPLOYMENT OF THE COVERED STENT, THE PATIENT DEVELOPED SLOW FLOW IN THE CORONARY ARTERIES. MEDICATIONS WERE ADMINISTERED. A TEMPORARY PACEMAKER WAS INSERTED FOR RHYTHM ASSISTANCE. AFTER PLACEMENT OF THE PACEMAKER, THE PATIENT DEVELOPED HYPOTENSION. PERICARDIOCENTESIS WAS STARTED; HOWEVER, THERE WAS NO FLUID OR BLOOD REMOVED. ECHOCARDIOGRAPHY WAS REQUESTED AND IMAGES REVEALED THERE WAS NO SIGNIFICANT PERICARDIAL EFFUSION OR TAMPONADE. CPR WAS CONTINUED. ATTEMPTS WERE MADE TO RECANNULATE THE LM, THIS FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 665181

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death