BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2151785 · Received July 6, 2011

    Report

    Report Number
    2024168-2011-04779
    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
    Product Problem
    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. THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL; GUIDE CATH: 7 FR XP 3.5; OTHER: INTRA AORTIC BALLOON PUMP. THE BALANCE MIDDLEWEIGHT GUIDE WIRE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. ADDITIONALLY, THE 4.0 X 16 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). FAILURE TO SEAL THE PERFORATION (THE REPORTED LEAK) MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, STENT GRAFT FOIL DAMAGE, PATIENT ANATOMICAL MORPHOLOGY, PRODUCT SIZE SELECTION, DEPLOYMENT TECHNIQUE (NON-CENTRAL POSITIONING OF STENT GRAFT OVER PERFORATION OR INADEQUATE OVERLAPPING), INTERFERENCE FROM PREVIOUSLY DEPLOYED DEVICES, OR GROWTH OF PERFORATION DURING DEPLOYMENT. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS (SDS) ARE 100% LEAK-TESTED AND VISUALLY INSPECTED FOR FOIL DAMAGE AND PROPER PLACEMENT. IT IS POSSIBLE THAT THE GRAFTMASTER STENT WAS NOT LONG ENOUGH OR POSITIONED CORRECTLY TO SEAL THE PERFORATION; HOWEVER, THIS COULD NOT BE CONFIRMED. IT WAS REPORTED THAT AFTER THE GRAFTMASTER STENT WAS IMPLANTED, THE PERFORATION CONTINUED TO LEAK AND ANOTHER GRAFTMASTER STENT WAS IMPLANTED. THE PATIENT LATER DIED. HEMORRHAGE AND DEATH ARE LISTED AS OBSERVED OR POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CORONARY STENTING IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE. DUE TO THE INHERENTLY EMERGENT AND SERIOUS USE OF THE GRAFTMASTER DEVICE, IT IS POSSIBLE THAT THE PERFORATION ITSELF AND/OR THE INABILITY TO TREAT THE PERFORATION MAY HAVE CONTRIBUTED TO THE REPORTED CASCADING PATIENT EFFECTS AND THE NEED FOR ADDITIONAL TREATMENTS THAT ULTIMATELY LEAD TO THE PATIENTS DEATH. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED PATIENT EFFECTS OR THEIR RELATIONSHIP TO THE DEVICE, IF ANY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED FAILURE TO SEAL AND THE REPORTED PATIENT EFFECTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    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 583061

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death