BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5709221 · Received June 9, 2016

    Report

    Report Number
    1820334-2016-00508
    Event Type
    Injury
    Date Received
    June 9, 2016
    Report Date
    May 30, 2016
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    P850049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PATIENTS AGE WAS REPORTED AS (B)(6) IN THE JOURNAL ARTICLE, IT IS UNKNOWN IF THIS WAS THE AGE AT THE TIME OF THE PUBLICATION, AGE WHEN THE ORIGINAL PROCEDURE WAS PERFORMED OR DATE OF THE MIGRATION DISCOVERY. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) WHICH LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS AND PRECAUTIONS, AND CORRECT DEPLOYMENT PROCEDURE. THE EXACT IFU IS DEPENDENT ON PRODUCT SIZE AND PLACEMENT APPROACH. WITHOUT THE EXACT DEVICE RPN, WE CANNOT DETERMINE THE EXACT IFU. HOWEVER, IN EACH IFU, PERFORATION OF VENA CAVA WALL IS LISTED AS A POTENTIAL ADVERSE EVENT. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY AND NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE WAS NOT POSSIBLE WITHOUT A LOT NUMBER. BASED ON THE AVAILABLE INFORMATION WE ARE UNABLE TO DRAW A CONCLUSION AS THE TO CAUSE OF THE FRACTURE REPORTED IN THIS CASE. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THE ARTICLE REPORTS NO COMPLICATIONS RELATED TO THE MIGRATED STRUT AND NO INTERVENTION TO REMOVE EITHER THE STRUT OR THE FILTER ITSELF. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION WILL BE CONDUCTED AT THIS TIME.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE ALLEGED THAT A (B)(6) WOMAN UNDERWENT PLACEMENT OF A BIRD'S NEST IVC FILTER IN THE INFERIOR VENACAVA 11 YEARS AGO; WHICH RESULTED IN MIGRATION OF THE STRUT. THE PATIENT RECOVERED WELL WITHOUT ANY RESIDUAL CLINICAL SIGNS OF PULMONARY HYPERTENSION. AN ABDOMINAL PLAIN FILM SOME YEARS AGO REVEALED THAT A STRUT FRAGMENT OF THE FILTER HAD MIGRATED INTO THE LIVER PARENCHYMA. AT THAT TIME, THE FILTER FUNCTION SEEMED TO BE INTACT WITHOUT ANY CLINICAL EVIDENCE OF RECURRENT PULMONARY THROMBOEMBOLISM. THERE WAS NO EVIDENCE OF CLINICAL SYMPTOMS OWING TO THIS STRUCTURAL FAILURE OF THE FILTER DEVICE AND THE PATIENT WAS FURTHER MANAGED CONSERVATIVELY. UP TO 6 YEARS LATER, CONTROL ABDOMINAL X-RAYS DID NOT REVEAL ANY CHANGES IN THE POSITION OF THE MIGRATED STRUT, WHICH WAS STILL LOCATED WITHIN THE LIVER PARENCHYMA, AS DEMONSTRATED BY CT SCAN. THE JOURNAL ARTICLE REPORTED: THE PATIENT IS STILL DOING WELL WITHOUT ANY COMPLAINTS OR CLINICAL SYMPTOMS RELATED TO THE MIGRATED STRUT THEREFORE, THE DECISION WAS MADE TO FOLLOW-UP ON THE PATIENT WITHOUT ANY ATTEMPT TO RETRIEVE THE FRAGMENT. JOURNAL ARTICLE: GEERT MALEUX1, ET AL: (2011) PENETRATION OF A FRACTURED BIRD'S NEST FILTER STRUT INTO THE LIVER PARENCHYMA ACTA RADIOLOGICA 2011: 643-645.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE ALLEGED THAT A (B)(6) YEAR OLD WOMAN UNDERWENT PLACEMENT OF A BIRD'S NEST IVC FILTER IN THE INFERIOR VENACAVA 11 YEARS AGO; WHICH RESULTED IN MIGRATION OF THE STRUT. THE PATIENT RECOVERED WELL WITHOUT ANY RESIDUAL CLINICAL SIGNS OF PULMONARY HYPERTENSION. AN ABDOMINAL PLAIN FILM SOME YEARS AGO REVEALED THAT A STRUT FRAGMENT OF THE FILTER HAD MIGRATED INTO THE LIVER PARENCHYMA. AT THAT TIME, THE FILTER FUNCTION SEEMED TO BE INTACT WITHOUT ANY CLINICAL EVIDENCE OF RECURRENT PULMONARY THROMBOEMBOLISM. THERE WAS NO EVIDENCE OF CLINICAL SYMPTOMS OWING TO THIS STRUCTURAL FAILURE OF THE FILTER DEVICE AND THE PATIENT WAS FURTHER MANAGED CONSERVATIVELY. UP TO 6 YEARS LATER, CONTROL ABDOMINAL X-RAYS DID NOT REVEAL ANY CHANGES IN THE POSITION OF THE MIGRATED STRUT, WHICH WAS STILL LOCATED WITHIN THE LIVER PARENCHYMA, AS DEMONSTRATED BY CT SCAN. THE JOURNAL ARTICLE REPORTED: THE PATIENT IS STILL DOING WELL WITHOUT ANY COMPLAINTS OR CLINICAL SYMPTOMS RELATED TO THE MIGRATED STRUT THEREFORE, THE DECISION WAS MADE TO FOLLOW-UP ON THE PATIENT WITHOUT ANY ATTEMPT TO RETRIEVE THE FRAGMENT. JOURNAL ARTICLE: GEERT MALEUX1, ET AL: (2011) PENETRATION OF A FRACTURED BIRD'S NEST FILTER STRUT INTO THE LIVER PARENCHYMA ACTA RADIOLOGICA 2011: 643-645.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364919 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other