BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOROOT WOVEN VASCULAR GRAFT

    MDR report key: 2230685 · Received August 12, 2011

    Report

    Report Number
    1640201-2011-00019
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 16, 2011
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K103347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFORMATION CONTAINED IN THIS REPORT IS PROVIDED BY THE MANUFACTURER. NO PRODUCT EVALUATION WAS PERFORMED SINCE THE GRAFT REMAINED IMPLANTED. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE COLLAGEN COATING RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. THE WATER PERMEABILITY TESTING PERFORMED ON SIX GRAFTS COATED ON THE SAME DAY AS THE COMPLAINT DEVICE DID NOT SHOW ANY POOR COLLAGEN ADHERENCE. IN ADDITION, IT SHOULD BE NOTED THAT A QC INSPECTION IS PERFORMED ON EVERY FINISHED GRAFT AND NO DEFECT WAS EVIDENCED ON THE COMPLAINT DEVICE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. HOWEVER, THE INVESTIGATION PERFORMED WOULD TEND TO INDICATE THAT THE PRODUCT WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REMODELING PROCEDURE WITH ANNULOPLASTY ON (B)(6), 2011. IT WAS REPORTED THAT THE PATIENT HAD A CEREBRAL EMBOLISM WITH POSITIVE CT (COMPUTED TOMOGRAPHY) A FEW WEEKS FOLLOWING THE OPERATION. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE HOSPITAL AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOROOT WOVEN VASCULAR GRAFT DSY INTERVASCULAR HEWROOT0026 10M23

    Patients

    Seq Age Sex Outcome Treatment
    1 Other