BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4123435 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06262
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. INVESTIGATION IS NOT COMPLETE. A FOLLOWUP WILL BE FILED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE STENT REMAINS IN THE ANATOMY. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE CORONARY STENT GRAFT SYSTEM, GRAFTMASTER RX INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 THE GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE LEFT MAIN (LM) WITH THE USE OF A NON-ABBOTT GUIDE WIRE DURING A PROCEDURE OF THE CHRONIC TOTALLY OCCLUDED (CTO) LESION. ON (B)(6) 2014 THE PATIENT PRESENTED WITH CHEST PAIN AND ANGIOGRAPHY CONFIRMED THAT THE PREVIOUSLY PLACED GRAFTMASTER STENT IN THE LM AND PROXIMAL CIRCUMFLEX (CX) ARTERIES WAS TOTALLY OCCLUDED WITH THROMBUS. REVASCULARIZATION WAS COMPLETED USING BALLOON ANGIOPLASTY AND RE-FLOW WAS ACHIEVED. TO PRECLUDE FUTURE POTENTIAL OCCLUSION BYPASS SURGERY WAS PERFORMED FOR THE LEFT ANTERIOR DESCENDING (LAD) AND PROXIMAL CX VESSEL. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602338 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 212194N

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R| S ASPIRIN, PLAVIX