BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3201928 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04141
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT WAS CONFIRMED. THE REPORTED PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION WITH DYE STAINING ON THE CORONARY ANGIOGRAM WAS NOTICED NEAR THE NON-ABBOTT STENT THAT WAS DEPLOYED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS, DISTAL LEFT CIRCUMFLEX CORONARY ARTERY. THE PERICARDIAL EFFUSION RESULTED FROM A CORONARY VESSEL PERFORATION AFTER THE NON-ABBOTT STENT WAS IMPLANTED. THE GRAFTMASTER WAS INSERTED TO TREAT THE EFFUSION AND ENCOUNTERED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE SHAFT OF THE GRAFTMASTER STENT DELIVERY SYSTEM SEPARATED OUTSIDE THE ANATOMY DURING ADVANCEMENT. SINCE THERE WAS NO OTHER GRAFTMASTER AVAILABLE, THE PATIENT WAS IMMEDIATELY SENT TO SURGERY FOR TREATMENT OF THE EFFUSION. THE SURGERY WAS SUCCESSFUL IN TREATING THE PERICARDIAL EFFUSION. THE PATIENT WAS IN THE CARDIAC CARE UNIT AND SCHEDULED TO BE DISCHARGED FROM THE HOSPITAL ON 6/29/2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302780 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 2121942

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention STENT: PROMUS ELEMENT 2.5X16