BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 5996001 · Received October 4, 2016

    Report

    Report Number
    1820334-2016-00942
    Event Type
    Death
    Date Received
    October 4, 2016
    Report Date
    July 17, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT INVOLVED WAS REPORTED TO BE DECEASED WITHOUT FURTHER DETAILS, THEREFORE THIS REPORT IS BEING SUBMITTED AS "DEATH" RELATED AS A CAUTIONARY MEASURE. 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 "PT SUFFERS FROM VENA CAVA PERFORATION, THE INABILITY TO RETRIEVE THE DEVICE, AND OTHER: STRAIGHTENING OF HOOK DURING REMOVAL ATTEMPT" COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. 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. FROM THE PUBLISHED SCIENTIFIC LITERATURE FILTER TILT INSIDE IVC AND/OR EMBEDMENT OF FILTER LEGS OR FILTER HOOK IN THE IVC WALL IS A WELL-KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL 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.

    Additional Manufacturer Narrative · 1

    NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT REPORTED. NO KNOWN DEVICE PROBLEM REPORTED. INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. IMPOSSIBLE TO COMMENT ON ALLEGED INJURIES. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CHANGED TO "IT IS ALLEGED THAT PATIENT WAS INJURED (DEATH) WITHOUT FURTHER EXPLANATION." (B)(4). INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. IMPOSSIBLE TO COMMENT ON ALLEGED INJURIES (DEATH). NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 03/23/2017 AS FOLLOWS: THE PATIENT ALLEGEDLY RECEIVED THE DEVICE IMPLANT ON (B)(6) 2009 AS TREATMENT FOR DVT AND PE DESPITE ANTICOAGULATION. THE PATIENT INVOLVED WAS REPORTED TO BE DECEASED WITHOUT FURTHER DETAILS.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE ¿PATIENT RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2009 AT (B)(6) HOSPITAL IN (B)(6).¿ 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 COOK GUNTHER TULIP ON (B)(6) 2009 AT (B)(6)." IT IS ALLEGED THAT PATIENT WAS INJURED (DEATH) WITHOUT FURTHER EXPLANATION. THE PATIENT'S PARTY IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647386 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O