BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY FILTER SYSTEM

    MDR report key: 2000634 · Received February 2, 2011

    Report

    Report Number
    2020394-2011-00016
    Event Type
    Injury
    Date Received
    February 2, 2011
    Report Date
    October 1, 2018
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER REMAINS IMPLANTED. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Additional Manufacturer Narrative · 1

    THE FILTER WAS RETURNED. ALL 6 FILTER LEGS WERE RETURNED ATTACHED TO THE BASE OF THE APEX. TWO OF THE FILTER LEGS WERE RETURNED OVERLAPPING EACH OTHER BY THEIR FEET. IT IS UNKNOWN HOW THE OVERLAP OCCURRED AS IT WAS NOT REPORTED. TWO OUT OF THE SIX FILTER LEGS EXHIBITED BROKEN FEET, AND THE FEET WERE NOT RETURNED WITH THE DEVICE. THE FILTER HAD 3 FULLY ATTACHED FILTER ARMS AT THE BASE OF THE APEX; THE OTHER THREE ARMS WERE BROKEN AT THE BASE OF THE APEX AND WERE NOT RETURNED FOR EVALUATION. NO OTHER ANOMALIES WERE NOTICED ON THE DEVICE. THE COMPLAINT INVESTIGATION IS CONFIRMED FOR TWO BROKEN FEET AND 3 BROKEN ARMS. THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNING: FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN REPORTS FOR EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. POTENTIAL COMPLICATIONS: POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN REPORTS FOR EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. MEDICAL RECORD REVIEW: THE PATIENT WITH A HISTORY OF PULMONARY EMBOLI AND DEEP VENOUS THROMBOSIS HAD A VENA CAVA FILTER DEPLOYED BELOW THE RENAL VEINS WITHOUT DIFFICULTY. THE PATIENT TOLERATED THE PROCEDURE WELL. APPROXIMATELY SIX YEARS POST FILTER DEPLOYMENT, THE PATIENT RETURNED WITH SYMPTOMS OF ABDOMINAL DISCOMFORT OF UNCLEAR ETIOLOGY. A COMPUTED TOMOGRAPHY SCAN DEMONSTRATED PENETRATION OF THE FILTER LEGS THROUGH THE INFERIOR VENA CAVA AND A DETACHED FRAGMENT OF THE FILTER. THE DECISION WAS MADE TO PROCEED WITH REMOVAL OF THE FILTER AND REPLACE WITH A NEW FILTER. THE FILTER WAS CAPTURED AND REMOVED WITHOUT DIFFICULTY. AN INFERIOR VENACAVOGRAM DEMONSTRATED NO SIGN OF ANY EXTRAVASATION AND NO THROMBUS. A NEW FILTER WAS THEN DEPLOYED IN A SUPRARENAL POSITION WITHOUT DIFFICULTY. THE PATIENT TOLERATED THE PROCEDURE WELL. INVESTIGATION SUMMARY: THE FILTER WAS RETURNED. THE COMPLAINT INVESTIGATION IS CONFIRMED FOR TWO BROKEN FEET AND THREE BROKEN ARMS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY SIX YEARS POST FILTER DEPLOYMENT, A CT SCAN DEMONSTRATED PENETRATION OF THE FILTER LEGS THROUGH THE INFERIOR VENA CAVA AND A DETACHED FRAGMENT OF THE FILTER. THE FILTER WAS REMOVED WITHOUT DIFFICULTY AND A NEW FILTER WAS THEN DEPLOYED IN A SUPRARENAL POSITION. THEREFORE, THE INVESTIGATION CAN BE CONFIRMED FOR LIMB DETACHMENT AND PERFORATION OF THE IVC. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT, RETRIEVAL DIFFICULTIES AND FILTER MIGRATION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN REPORTS FOR EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (B)(4).

    Description of Event or Problem · 1

    THE FILTER WAS REMOVED WITHOUT INCIDENT AND ANOTHER IVC FILTER WAS THEN IMPLANTED IN THE PATIENT WITHOUT ANY COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN SIX YEARS POST FILTER IMPLANT. AN MRI DEMONSTRATED THAT ONE OF THE FILTER LIMBS HAD DETACHED AND WAS EXTENDING THROUGH THE WALL OF THE IVC. THE PHYSICIAN REPORTED THAT HE FELT THAT THE PATIENT'S PAIN WAS NOT RELATED TO THE FILTER. THERE HAS BEEN NO INTERVENTION TO DATE. ADDITIONAL INFORMATION IS PENDING. ADDITIONAL INFORMATION RECEIVED: THE FILTER WAS REMOVED WITHOUT INCIDENT AND ANOTHER IVC FILTER WAS THEN IMPLANTED IN THE PATIENT WITHOUT ANY COMPLICATIONS. NEW INFORMATION: IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM AND IN CONJUNCTION WITH OR BEFORE AN ORTHOPEDIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER HAD TILTED AND EMBEDDED IN THE WALL OF THE IVC, PERFORATED THE IVC, AND MIGRATED. IT WAS FURTHER ALLEGED THAT DETACHED FILTER STRUTS WERE LOCATED IN THE UPPER AND LOWER ABDOMINAL AREAS. THE DEVICE HAS NOT BEEN REMOVED AFTER TWO ATTEMPTED BUT UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURES. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND ABDOMINAL BLEEDING FROM THE DETACHED, MIGRATING PIECES; HOWEVER; THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED WITH PAIN SIX YEARS POST FILTER IMPLANT. AN MRI DEMONSTRATED THAT ONE OF THE FILTER LIMBS HAD DETACHED AND WAS EXTENDING THROUGH THE WALL OF THE IVC. THE PHYSICIAN REPORTED THAT HE FELT THAT THE PATIENT'S PAIN WAS NOT RELATED TO THE FILTER. THERE HAS BEEN NO INTERVENTION TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFOI2662

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention