BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP

    MDR report key: 25331029 · Received May 29, 2026

    Report

    Report Number
    9612452-2026-00018
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 29, 2026
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04038653918164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: PRODUCT REFERENCE 5010024 IS SIMILAR TO THE PRODUCT REFERENCE CLEARED UNDER #510K240578. THE COMPLAINT CONCERNS 1 UNIT OF VENATECH LP REFERENCE 5010024 FROM BATCH 37003363. DEVICE HISTORY RECORD: BATCH RECORD FILE NUMBER 37003363 WAS REVIEWED: THE BATCH WAS MANUFACTURED WITHIN THE SPECIFICATIONS AND NO DISCREPANCY WAS OBSERVED DURING INSPECTION STEPS. NO OTHER COMPLAINT WAS REPORTED ON THIS BATCH RELEASED IN NOVEMBER 2022. SUMMARY OF INVESTIGATION: 3 X-RAY PICTURES WERE TRANSMITTED FOR INVESTIGATION. THE VENATECH LP FILTER IS STILL IMPLANTED INTO PATIENT'S BODY AND THE INTRODUCTION SYSTEM WAS NOT RETURNED FOR INVESTIGATION X-RAYS PICTURE REVIEW: X-RAY PICTURES TAKEN JUST AFTER IMPLANTATION: CAVOGRAPHY IMAGE: THE VCF IS UNDEPLOYED, THE FILTERS' LEGS LOOK CONSTRAINED. THE FILTER IS LOCATED AGAINST THE VENA CAVA WALL, ITS LOWER PART LOOKS PRESSED AGAINST IT. THE EXTREMITY OF THE INTRODUCER SHEATH IS VISIBLE ABOVE THE VCF. X-RAY IMAGE: THE VCF IS SLIGHTLY MORE DEPLOYED THAN ON THE CAVOGRAPHY IMAGE. ONE OF THE UPPER ARM IS SLIGHTLY OPENED. THE FILTER HEAD IS LOCATED AT THE LEVEL OF THE LAST RIB, NORMALLY SITUATED AT T12. X-RAY PICTURES TAKEN 2 WEEKS AFTER THE IMPLANTATION: THE FILTER'S HEAD IS STILL LOCATED AT THE LEVEL OF THE LAST RIB. THE FILTER IS ASYMMETRICALLY OPENED. RAW MATERIAL HISTORICAL REVIEW: THE RAW MATERIAL USED FOR THE VENA CAVA FILTER BATCHES INCLUDED IN THE DEVICE KIT WAS VERIFIED. THE INCOMING QUALITY CONTROLS WERE WITHIN THE DEFINED SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. MANUFACTURING PROCESS REVIEW: ALL THE MANUFACTURING STEPS THAT COULD LEAD TO THE OBSERVED DEFECT WERE REVIEWED AND NO FAILURE WAS DETECTED. ROOT CAUSE: ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER, THE VCF NON-OPENING RESULTS FROM THE FACT IT WAS PARTIALLY RELEASED IN THE GONADAL VEIN. ACCORDING TO THE HOSPITAL PROTOCOL IN THIS KIND OF SITUATION, THE VCF WAS LEFT IN PLACE AND A 2-WEEK FOLLOW-UP WAS PERFORMED, FINDING THE VCF "PARTIALLY OPENED INTO ITS FILTERING STATE". THE REVIEW OF THE IMAGES TAKEN ALLOWS US TO SEE THAT THERE WAS NO MIGRATION UPWARD OF THE FILTER UPWARD TO THE HEART. CONCLUSION: THE VENA CAVA FILTER NON-OPENING RESULTS FROM AN INCORRECT PLACEMENT OF THE FILTER DURING ITS DEPLOYMENT. THE PLACEMENT OF THE FILTER IS CLEARLY DESCRIBED AND REPRESENTED IN OUR IFU RECOMMENDATIONS. NO LABELLING DEFECT IS AT THE ORIGIN OF THIS INCIDENT. IN ADDITION, IT IS WORTH NOTING THAT NO ABNORMALITY WAS FOUND ON THE RAW MATERIAL USED AND DURING OUR MANUFACTURING PROCESS. THE BATCH INVOLVED WAS PRODUCED WITHIN OUR SPECIFICATIONS. NO OTHER COMPLAINT WAS REPORTED ON THIS BATCH. THIS TYPE OF INCIDENT IS RARE. NO ACTIONS PLAN IS FORESEEN AT THAT TIME.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: FILTER DID NOT FULLY DEPLOY AT THE TIME OF IMPLANT AND HAS SINCE "OPENED" UP MORE TO ABOUT 50% THEY CAN'T RETURN IT, IT'S STILL IN THE PATIENT. THE PATIENT IS MOST LIKELY GOING TO A DIFFERENT HOSPITAL TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22147 VENATECH LP VENA CAVA FILTER DTK B.BRAUN MEDICAL SAS 5010024 37003363 04038653918164

    Patients

    Seq Age Sex Outcome Treatment
    1