BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6093945 · Received November 10, 2016

    Report

    Report Number
    1820334-2016-01160
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    August 16, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER REFERENCE # 3002808486-2016-00093. ADDITIONAL INFORMATION PROVIDED DETERMINED THIS DEVICE WAS MANUFACTURED BY CINC. EVALUATION: THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. NO NOTES OF RELEVANCE FOUND IN THE DEVICE WORK ORDER, NOR ON THE FILTER LOT NUMBER. NO OTHER COMPLAINTS HAVE BEEN RECEIVED RELEVANT TO THIS LOT. IMPOSSIBLE TO COMMENT ON THE ALLEGED INJURIES. DEVICE MANUFACTURED/INSPECTED ACCORDING TO SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST A DEVICE FAILURE. 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

    ADDITIONAL INFORMATION: INVESTIGATION EVALUATION: 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 "TULIP, DEVICE UNABLE TO RETRIEVE, EXCESSIVE BLEEDING REQUIRING HYSTERECTOMY, PAIN - SIDE". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. UNKNOWN IF THE REPORTED PAIN AND EXCESSIVE BLEEDING REQUIRING HYSTERECTOMY ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA BASE ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT MALFUNCTION. SERIOUS INJURY TO MALFUNCTION. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION- THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. NO NOTES OF RELEVANCE FOUND IN THE DEVICE WORK ORDER, NOR ON THE FILTER LOT NUMBER. NO OTHER COMPLAINTS HAVE BEEN RECEIVED RELEVANT TO THIS LOT. IMPOSSIBLE TO COMMENT ON THE ALLEGED INJURIES. DEVICE MANUFACTURED/INSPECTED ACCORDING TO SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST A DEVICE FAILURE. 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

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2009 AT (B)(6) MEDICAL CENTER." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 04/25/2016 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED THE DEVICE IMPLANT ON (B)(6) 2009 VIA RIGHT INTERNAL JUGULAR DUE TO HIGH RISK OF DVT AND PE ARISING FROM SUPER MORBID OBESITY, AND PLACEMENT OF A GASTRIC BY-PASS SLEEVE. PLAINTIFF IS ALLEGING AN UNSUCCESSFUL ATTEMPT TO RETRIEVE THE FILTER ALLEGEDLY OCCURRED ON (B)(6) 2009. THE PLAINTIFF ALLEGES A SECOND UNSUCCESSFUL ATTEMPT TO RETRIEVE THE FILTER ALLEGEDLY OCCURRED ON (B)(6) 2009 .THE PLAINTIFF ALLEGES THE DEVICE IS UNABLE TO BE RETRIEVED, EXCESSIVE BLEEDING REQUIRING A HYSTERECTOMY, AND PAIN.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2009 AT (B)(6) MEDICAL CENTER, (B)(6)". PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746050 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other