BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2840454 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07324
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2008
    Report Date
    October 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. ADD'L DEVICES: GUIDE WIRE: BALANCE MIDDLEWEIGHT (X2); GUIDE CATH: 6F CORDIS; STENT: 4.0 X 28 MM VISION, 3.5 X 23 MM VISION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE 3.0 X 20 MM VOYAGER REFERENCED AND THE 3.5 X 23 MM VISION REFERENCED ARE BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) THAT HAD TWO AREAS OF STENOSIS OF 90 AND 95%. TWO BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRES WERE ADVANCED INTO THE POSTERIOR DESCENDING ARTERY TO ENHANCE SUPPORT. PRE-DILATATION WAS PERFORMED WITH A 3.0X20 MM VOYAGER BALLOON CATHETER AFTER WHICH A MID-DISTAL DISSECTION WAS OBSERVED. THE MID RCA WAS STENTED WITH A 4.0X28 MM VISION STENT WITH GOOD RESULTS AND THE PROXIMAL RCA WAS STENTED WITH A 3.5X23 MM VISION STENT (SOMEWHAT UNDERSIZED). IMMEDIATELY AFTER STENT DEPLOYMENT THE PATIENT WENT INTO A STATE OF SHOCK HYPOTENSION AND BRADYCARDIA. CONTRAST INJECTION SHOWED A GRADE 3 CORONARY PERFORATION WITH BLOOD EMERGING FROM MULTIPLE PERFORATIONS IN THE PROXIMAL STENTED SEGMENT INTO THE PERICARDIAL SPACE. PATIENT WENT INTO CARDIAC TAMOPONADE AND CARDIOGENIC SHOCK INSTANTLY. MEDICATIONS WERE ADMINISTERED AND A 3.5X20 MM VOYAGER BALLOON WAS INFLATED TO OCCLUDE THE PERFORATED VESSEL SUCCESSFULLY. A DOC EXTENSION WAS ATTACHED TO THE BMW GUIDE WIRE AND THE VOYAGER WAS DEFLATED WHILE A 4.0X19 MM GRAFTMASTER STENT WAS DEPLOYED IN THE PROXIMAL RCA. THE BLEEDING WAS SIGNIFICANTLY REDUCED; HOWEVER, NOT COMPLETELY. THE PATIENT WAS PROFOUNDLY HYPERTENSIVE. AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED AND HER BLOOD PRESSURE WAS STABILIZED. THE DECISION WAS MADE TO DRAIN THE SMALL AMOUNT OF BLOOD IN THE PERICARDIAL SPACE BY PERFORMING PERICARDIOCENTESIS. REPEAT VISUALIZATION OF THE RCA AND THE LEFT CORONARY ARTERY CONFIRMED ABSENCE OF BLEEDING. IABP WAS REMOVED APPROXIMATELY 5 HOURS POST PROCEDURE. PATIENT WAS DISCHARGED TO HOME AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention