BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 5885766 · Received August 18, 2016

    Report

    Report Number
    1820334-2016-00805
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Report Date
    April 16, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED.

    Description of Event or Problem · 0

    ATTEMPTED RETRIEVAL ON (B)(6) 2007 WAS UNSUCCESSFUL.. PER OPERATIVE NOTE (ATTEMPTED FILTER RETRIEVAL), DATED (B)(6) 2007, "INFERIOR VENA CAVOGRAM WAS PERFORMED. THE FILTER WAS NOTED TO BE TILTED IN THE INFERIOR VENA CAVA. MULTIPLE ATTEMPTS TO REMOVE THE FILTER WERE PERFORMED, UNABLE TO RECAPTURE THE ENTIRE FILTER. UNSUCCESSFUL ATTEMPT TO REMOVE THE INFERIOR VENA CAVA FILTER."

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    EVALUATION- NO INFORMATION REGARDING THE EVENT. THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. UNABLE TO COMMENT ON THE ALLEGED INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K) - K032426. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING " PHYSICIAN ATTEMPTED AN UNSUCCESSFUL JUGULAR RETRIEVAL. NO FURTHER ATTEMPTS." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. ACCORDING TO DEVICE HISTORY RECORDS, BASED ON THE LOT NUMBER PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS OR THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G., THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2007 AT (B)(6) HOSPITAL. THE IMPLANTING PHYSICIAN IS UNKNOWN. IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2007 AT (B)(6) HOSPITAL IN (B)(6). THE IMPLANTING PHYSICIAN IS UNKNOWN. IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 2/14/17 - PATIENT ALLEGES IVC IMPLANT ON (B)(6) 2007. THE REASON FOR THE IMPLANT WAS RIGHT PULMONARY EMBOLI AND LEFT PULMONARY EFFUSION. ON (B)(6) 2007, PHYSICIAN ATTEMPTED AN UNSUCCESSFUL JUGULAR RETRIEVAL. NO FURTHER ATTEMPTS. PATIENT REMAINS CONCERNED THAT SHE WILL SUFFER ADDITIONAL INJURY AND/OR DEATH BECAUSE OF THE RETAINED FILTER.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGES THE DEVICE IS UNABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538443 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other