BEUDAMED
    FDA Adverse Event Death Summary report: N

    RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM

    MDR report key: 3111590 · Received May 14, 2013

    Report

    Report Number
    2025587-2013-00074
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    March 19, 2013
    Report Date
    June 7, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    KRH
    PMA / PMN Number
    K101212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THERE WAS NO REPORT OF A DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. BASED ON THE AVAILABLE INFORMATION, USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. CONCLUSION: THE DEVICE HISTORY REVIEW IS PENDING. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. INVESTIGATION CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS NOT EXPLANTED FROM THE PATIENT. A CONCLUSIVE CAUSE OF THE OBSERVED ATRIOVENTRICULAR BLEEDING AND VENA CAVA TEAR AND SUBSEQUENT PATIENT DEATH COULD NOT BE DETERMINED. HOWEVER, IT WAS REPORTED BY THE DOCTOR THAT THE DEVICE WAS NOT DIRECTLY RELATED TO THE PATIENT¿S DEATH, BUT RATHER IMPLANT TECHNIQUE. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION WAS MADE ON THIS REPORT TO REFLECT THE CORRECT AWARE DATE OF THE ADDITIONAL INFORMATION WHICH WAS INADVERTANTLY NOT CORRECTED ON THE LAST SUPPLEMENTAL REPORT. THE CORRECT AWARE DATE OF THE ADDITINAL INFORMATION SHOULD BE (B)(4), 2013.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE END OF THE SURGERY OF THIS ANNULOPLASTY RING IN THE TRICUSPID POSITION, THE PHYSICIAN OBSERVED BLEEDING WITH ATRIOVENTRICULAR AND A VENA CAVA TEARING. THE PHYSICIAN REPAIRED THE TEAR WITH A BOVINE PERICARDIUM AND IT WAS REINFORCED WITH SYNTHETIC GLUE AND A PERICARDIO PATCH. SUBSEQUENTLY, THE PATIENT DIED IN THE SURGERY ROOM. IT WAS REPORTED BY THE DOCTOR THAT THE DEVICE WAS NOT DIRECTLY RELATED TO THE DEATH, BUT RATHER IMPLANT TECHNIQUE. THE DEVICE WILL NOT BE RETURNED, AS THE DEVICE WAS NOT EXPLANTED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213171 RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM RING, ANNULOPLASTY KRH HEART VALVES SANTA ANA 690R

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death