BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

    MDR report key: 8401862 · Received March 7, 2019

    Report

    Report Number
    1640201-2019-00017
    Event Type
    Injury
    Date Received
    March 7, 2019
    Report Date
    July 3, 2019
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    MAL
    PMA / PMN Number
    K021213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA IN BLOCK D1 - EVEN IF THE ARTICLE DOES NOT SPECIFY IT, THE IMPLANT LOCATION OF THE GRAFT AND THE DIAMETER MENTIONED SUGGEST THAT THE INVOLVED GRAFT IS AN HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR. (61) THE ARTICLE WAS REVIEWED BY OUR CORPORATE MEDICAL OFFICER WHO PROVIDED HIS ASSESSMENT AS FOLLOWS: "GRAFT KINKING IN THE THORACIC AREA IS MOSTLY (IF NOT ONLY) DUE TO INCORRECT LENGTH OF THE VASCULAR GRAFT AT IMPLANT. IF THE GRAFT IS TOO LONG IT WILL KINK WHEN THE CHEST IS CLOSED. IT WOULD NOT BE VISIBLE BY THE SURGEON AND IT WILL COMPLICATE THE POST-OPERATIVE COURSE IF THE KINK CAUSES A SIGNIFICANT IMPAIRMENT OF THE BLOOD FLOW. THIS APPEARS TO BE THE MOST PROBABLE CAUSE FOR THE EVENT DESCRIBED IN THE ARTICLE." THE KINKING OBSERVED WAS PROBABLY DUE TO A USE ERROR DURING INITIAL PROCEDURE AND NOT TO A GRAFT DEFECT.

    Additional Manufacturer Narrative · 0

    EXEMPTION E2017024 : INTERVASCULAR SAS (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF MAQUET CARDIOVASCULAR, LLC (IMPORTER). (4117) DEVICE IS NOT ACCESSIBLE FOR TESTING SINCE IT REMAINED IMPLANTED IN PATIENT. (4118) NO INVESTIGATION COULD BE PERFORMED TO DATE SINCE THERE IS NO GRAFT IDENTIFICATION AVAILABLE. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THIS IS A PUBLISHED CASE REPORT OF MICROANGIOPATHIC HEMOLYTIC ANEMIA AND HEMOGLOBINURIC ACUTE KIDNEY INJURY (AKI) PRESENTING 9 DAYS AFTER REPAIR OF AN ASCENDING AORTIC DISSECTION WITH A PROSTHETIC GRAFT. AFTER AN UNREMARKABLE RECOVERY FOLLOWING THE INITIAL PROCEDURE, THE PATIENT PRESENTED ON POSTOPERATIVE DAY 9 WITH DYSPNEA, FATIGUE, AND COLA-COLORED URINE. A FOLLOW-UP MRI/A REVEALED A KINK IN THE AORTIC GRAFT CAUSING TURBULENT BLOOD FLOW. AFTER SURGICAL RELEASE OF THE KINKED GRAFT, HIS AKI AND HEMOLYSIS LABS IMPROVED IMMEDIATELY. ON FOLLOW-UP, HIS ANEMIA RESOLVED, AND RENAL FUNCTION RETURNED TO BASELINE, ALTHOUGH HE CONTINUED TO HAVE SUBCLINICAL HEMOLYSIS. THE HEMOLYSIS AND HEMOGLOBINURIC AKI SEEN IN THIS PATIENT WAS DIRECTLY THE RESULT OF A KINK IN THE NONVALVULAR PROSTHETIC AORTIC GRAFT. THE AUTHORS SPECULATE THAT WITHOUT APPROPRIATE SURGICAL REPAIR THE ONGOING HEMOLYSIS WOULD HAVE LED TO IRREVERSIBLE END-STAGE RENAL DISEASE AND LIFE-THREATENING TRANSFUSION-DEPENDENT ANEMIA. THE REFERENCE OF THE ARTICLE IS THE FOLLOWING: SHEELVANTH HV, ET AL. HEMOGLOBINURIC ACUTE KIDNEY INJURY IN A PATIENT WITH A KINKED PROSTHETIC AORTIC GRAFT. CLIN NEPHROL 2018;89(4):286-290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192184 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR POLYESTER GRAFT MAL INTERVASCULAR SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention