BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH FILTER

    MDR report key: 8834413 · Received July 27, 2019

    Report

    Report Number
    9612452-2019-00086
    Event Type
    Injury
    Date Received
    July 27, 2019
    Date of Event
    March 29, 2017
    Report Date
    September 12, 2019
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    PMA / PMN Number
    K010485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 08/22/2019, THE IMPORTER WAS INFORMED BY PRESERVE STUDY THAT THIS CASE PREVIOUSLY JUDGED AS "POSSIBLY RELATED TO THE DEVICE" IS NOW JUDGED AS "NOT RELATED". THE BATCH NUMBER OF HE INVOLVED DEVICE IS STILL UNKNOWN BUT THE MANUFACTURER CLOSES THE FILE AS THE CASE IS NOT IMPUTABLE TO THE DEVICE. B.BRAUN MEDICAL SAS IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORTED INCIDENT HAS NOT BEEN SUBSTANTIATED BY ANY VERIFIABLE INFORMATION (E.G. FILMS OR MEDICAL RECORDS) THAT COULD BE USED TO INVESTIGATE THE VERACITY OF THE ALLEGED INCIDENT OR RELATION TO THE DEVICE OR PROCEDURE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR CONCLUSION BY B.BRAUN MEDICAL SAS OR ITS EMPLOYEES THAT THE DEVICE, B.BRAUN MEDICAL SAS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    PATIENT ENROLLED IN PRESERVE ON (B)(6) 2017 WITH A VENATECH LP VENA CAVA FILTER PLACED THE SAME FOR CONTRAINDICATION TO ANTICOAGULATION DUE TO HISTORY OF DVT, HEMORRHAGIC CONVERSION OF A RECENT LEFT OCCIPITAL CVA AND CHRONIC LEFT FOOT ISCHEMIA. PATIENT HAS A RESOLVED BILATERAL SEGMENTAL PE AND CURRENT LEFT LOWER EXTREMITY DVT IN THE COMMON FEMORAL VEIN AS WELL AS RIGHT LOWER EXTREMITY DVT LIMITED TO BELOW THE POPLITEAL VEIN. SUBJECT DISCHARGE ON (B)(6) 2017 BUT RE-ADMITTED TO HOSPITAL WITH SEVERE GI BLEED COMPLICATED BY ANTICOAGULATION USED ON (B)(6) 2017. THE EVENT WAS CONSIDERED POSSIBLY RELATED TO THE IVC FILTER OR PROCEDURE AND WAS ONGOING WHEN THE SUBJECT DIED FROM PROGRESSION OF METASTATIC ADENOCARCINOMA. ON 08/22/2019: PRESERVE STUDY PROVIDED UPDATED INFORMATION VIA EMAIL. CHANGED EVENT RELATED TO THE IVC FILTER DEVICE FROM: POSSIBLY RELATED TO NOT RELATED.

    Additional Manufacturer Narrative · 1

    THE INVOLVED BATCH NUMBER IS UNKNOWN. THE INFORMATION AVAILABLE IS INSUFFICIENT. NO X-RAYS FILMS OR MEDICAL REPORTS WERE RETURNED FOR ANALYSIS. NO INVESTIGATION CAN BE PERFORMED. NO CONCLUSION CAN BE DRAWN. HOWEVER THE REVIEW OF OUR COMPLAINT DATA BASE DOES NOT ALLOW US TO DETECT ANY OTHER SIMILAR CASE.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN (B)(6) ON (B)(6) 2017 WITH A VENATECH LP VENA CAVA FILTER PLACED THE SAME FOR CONTRAINDICATION TO ANTICOAGULATION DUE TO HISTORY OF DVT, HEMORRHAGIC CONVERSION OF A RECENT LEFT OCCIPITAL CVA AND CHRONIC LEFT FOOT ISCHEMIA. PATIENT HAS A RESOLVED BILATERAL SEGMENTAL PE AND CURRENT LEFT LOWER EXTREMITY DVT IN THE COMMON FEMORAL VEIN AS WELL AS RIGHT LOWER EXTREMITY DVT LIMITED TO BELOW THE POPLITEAL VEIN. SUBJECT DISCHARGE ON (B)(6) 2017 BUT RE-ADMITTED TO HOSPITAL WITH SEVERE GI BLEED COMPLICATED BY ANTICOAGULATION USED ON (B)(6) 2017. THE EVENT WAS CONSIDERED POSSIBLY RELATED TO THE IVC FILTER OR PROCEDURE AND WAS ONGOING WHEN THE SUBJECT DIED FROM PROGRESSION OF METASTATIC ADENOCARCINOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628368 VENATECH FILTER VENATECH LP FILTER DTK B.BRAUN MEDICAL SAS 31335

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization