BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARBOMEDICS CARBO-SEAL VALSALVA

    MDR report key: 2170095 · Received June 17, 2011

    Report

    Report Number
    3005687633-2011-00001
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 17, 2011
    Manufacturer
    SORIN BIOMEDICA CARDIO S.R.L.
    Product Code
    LWQ
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(4) 2011; AN EVALUATION SUMMARY WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SERIAL NUMBER WAS NOT AVAILABLE UNTIL THE DEVICE WAS RECEIVED; THEREFORE, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED PRIOR TO SUBMISSION OF THIS REPORT. THE INVESTIGATION OF THIS EVENT WILL BE COORDINATED WITH VASCUTEK - THE MANUFACTURER OF THE GRAFT PORTION OF THE DEVICE. ADDITIONAL INFORMATION: THE INSTRUCTIONS FOR USE (IFU) FOR THIS DEVICE INDICATES IN THE WARNING AND PRECAUTIONS SECTION THAT "THIS PRODUCT SHOULD NOT BE IMPLANTED IN PATIENTS WHO EXHIBIT SENSITIVITY TO POLYESTER OR MATERIALS OF BOVINE ORIGIN." IN REGARDS TO THE GRAFT PORTION OF THE DEVICE, THE ADVERSE EVENTS SECTION OF THE IFU INDICATES ONE OF THE ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH THE USE OF VASCULAR GRAFTS INCLUDE: "COLLAGEN HAS BEEN SHOWN TO BE A WEAK IMMUNOGEN; CLINICAL REACTIONS TO COLLAGEN IMPLANTATION HAVE BEEN DESCRIBED AS INFREQUENT, MILD, LOCALIZED, AND SELF-LIMITING." THE IFU ALSO INDICATES THAT SUCH A REACTION COULD LEAD TO: REOPERATION, EXPLANTATION, PERMANENT DISABILITY, DEATH.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON (B)(4) 2011, OF A POTENTIAL IMMUNE RESPONSE BY A PATIENT TO THE GELATIN-COATED AORTIC GRAFT PORTION OF A CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (MODEL CP-029, SIZE 29 MM, S/N (B)(4)). THIS DEVICE CONSISTS OF A CARBOMEDICS STANDARD AORTIC MECHANICAL VALVE AND A WOVEN POLYESTER CONDUIT COATED WITH BOVINE GELATIN (VASCUTEK GELWEAVE). THE MECHANICAL VALVE PORTION OF THE DEVICE WAS REPORTED TO BE FUNCTIONING AS DESIGNED PRIOR TO EXPLANT. THE DEVICE WAS EXPLANTED ON (B)(6) 2011 AND REPLACED WITH A CARBOMEDICS MECHANICAL VALVE AND A VASCUTEK GRAFT MADE FROM A TRIPLEX GRAFT MATERIAL, WHICH DOES NOT CONTAIN BOVINE COLLAGEN OR GELATIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS CARBO-SEAL VALSALVA AORTO-VALVULAR PROSTHESIS LWQ SORIN BIOMEDICA CARDIO S.R.L. CP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention