BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2180054 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05269
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    B)(4). THE CASCADE OF PATIENT EFFECTS SUCH AS THE CARDIAC TAMPONADE, SURGERY, AND HOSPITALIZATION, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED GRAFTMASTER STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE SHAFT, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE INNER MEMBER WAS BUNCHED INSIDE THE HUB, FOR A LENGTH OF 1 CM. THERE WAS A KINK IN THE SHAFT AT THE DISTAL END OF THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED KINK. A KINK CAN OCCUR DURING MANUFACTURING, REMOVAL FROM THE PACKAGING AT THE ACCOUNT OR FROM HANDLING OF THE PRODUCT DURING PREPARATION FOR USE. IN THIS CASE, THERE WAS NO DAMAGE NOTED TO THE SHAFT OR INNER MEMBER DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT THE SDS WAS NOT PROPERLY SUPPORTED DURING ADVANCEMENT OVER THE GUIDE WIRE, RESULTING IN THE KINK AND NOTED INNER MEMBER BUNCHING. HEMORRHAGE IS LISTED AS AN OBSERVED OR POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENTING IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU). DUE TO THE INHERENTLY SERIOUS AND EMERGENT USE OF THE GRAFTMASTER DEVICE, THE LEAK ITSELF AND/OR THE FAILURE TO TREAT THE LEAK MAY HAVE POSSIBLY RESULTED IN A CASCADE OF PATIENT EFFECTS SUCH AS HEMORRHAGE; HOWEVER, THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MID AND PROXIMAL RIGHT CORONARY ARTERY (RCA), A ROTABLATOR WAS USED FOLLOWED BY STENTING OF THE MID RCA AND STENTING OF THE PROXIMAL RCA. DURING A 3.5 MM X 38 MM NON-ABBOTT POST STENT DILATATION OF THE PROXIMAL RCA A PERFORATION WAS NOTED. A 3.5X19 GRAFTMASTER WAS ATTEMPTED BUT DURING ADVANCING ON THE GUIDE WIRE OUTSIDE THE ANATOMY, THE DELIVERY SYSTEM SHAFT KINKED. THE DEVICE WAS NOT USED IN THE PROCEDURE. A SECOND 3.5X16 GRAFTMASTER WAS SUCCESSFULLY DEPLOYED AND SEALED THE PERFORATION. IT WAS NOTED THAT THE PATIENT WAS SENT TO SURGERY FOR A PERICARDIAL WINDOW DUE TO THE EFFUSION WHICH RESULTED IN TAMPONADE. POST PROCEDURE THE PATIENT WAS REPORTED AS STABLE AND DOING WELL, BUT REMAINED HOSPITALIZED IN THE INTENSIVE CARE UNIT. THOUGH REQUESTED, 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 640916

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R