BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5694546 · Received June 2, 2016

    Report

    Report Number
    1820334-2016-00484
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Report Date
    June 6, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT INVESTIGATION - NO PRODUCT WAS RETURNED AND NO IMAGING PROVIDED TO ASSIST WITH THE INVESTIGATION. BASED ON LIMITED INFORMATION PROVIDED THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE TULIP FILTER APPROX. 8½ YEARS AFTER IMPLANT CANNOT BE DETERMINED. 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. ALSO, 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. DIFFICULT FILTER RETRIEVAL DUE TO EMBEDMENT OF FILTER LEGS IN THE IVC WALL IS A WELL-KNOWN RISK IN THE LITERATURE, TOO. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL ENDOVASCULAR RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. LOT AND CATALOG NUMBER WAS NOT PROVIDED; HOWEVER THE TULIP FILTER IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATION. INVESTIGATION FOUND 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. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. IF ADDITIONAL INFORMATION IS FORTHCOMING, ADDITIONAL REPORT WILL BE CREATED TO CAPTURE THAT NEW INFORMATION. COOK, INC. WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    PATIENT CODE: NO KNOWN CONSEQUENCES REPORTED. DEVICE CODE: NO KNOWN DEVICE PROBLEM. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (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, "THE PLAINTIFF ALLEGEDLY RECEIVED THE FILTER IMPLANT VIA RIGHT COMMON FEMORAL VEIN ON (B)(6) 2007 DUE TO THE EXISTENCE OF A ¿THICK, STREAM-LIKE FREE-FLOATING CLOT AT THE LEVEL OF THE RENAL VEINS EXTENDING TO THE SUPRAHEPATIC IVC.¿ (NOTE: THE PATIENT HAD A SECOND COOK FILTER IMPLANTED ON (B)(6) 2007. THIS COMPLAINT ADDRESSES ONLY THE FILTER PLACED ON (B)(6) 2007.) THE PLAINTIFF CURRENTLY MAKES NO ALLEGATIONS REGARDING THIS DEVICE." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT PATIENT RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2007 AT (B)(6). IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS ALSO SEEKING PUNITIVE DAMAGES. MEDICAL RECORDS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION. ON (B)(6) 2007, MS. (B)(6) HAD TWO SEPARATE GUNTHER TULIP FILTERS IMPLANTED IN HER INFERIOR VENA CAVA. ON (B)(6) 2016, AN ATTEMPT WAS MADE TO REMOVE ONE OF THE GUNTHER TULIP FILTERS BUT THE DOCTORS WERE UNSUCCESSFUL. BOTH TULIP FILTERS ARE CURRENTLY EMBEDDED IN HER VENA CAVA AND NOT ABLE TO BE REMOVED. THE PATIENT ALLEGES TO HAVE SUFFERED INJURIES.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT PATIENT RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2007 AT (B)(6) MEDICAL CENTER, (B)(6) BY (B)(6). IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS ALSO SEEKING PUNITIVE DAMAGES. MEDICAL RECORDS HAVE NOT BEEN PROVIDED. PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 06/14/2016 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED THE FILTER IMPLANT VIA RIGHT COMMON FEMORAL VEIN ON (B)(6) 2007 DUE TO THE EXISTENCE OF A ¿THICK, STREAM-LIKE FREE-FLOATING CLOT AT THE LEVEL OF THE RENAL VEINS EXTENDING TO THE SUPRAHEPATIC IVC.¿ (NOTE: THE PATIENT HAD A SECOND COOK FILTER IMPLANTED ON (B)(6) 2007. THIS COMPLAINT ADDRESSES ONLY THE FILTER PLACED ON (B)(6) 2007.) THE PLAINTIFF CURRENTLY MAKES NO ALLEGATIONS REGARDING THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349583 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other