BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 9080292 · Received September 18, 2019

    Report

    Report Number
    3002808486-2019-01492
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Report Date
    September 18, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). THIS MDR WAS MISTAKENLY SUBMITTED WITH MANUFACTURING NUMBER FOR COOK MEDICAL LLC (3005580113-2019-00130) INSTEAD OF MANUFACTURING NUMBER FOR WILLIAM COOK EUROPE. CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION WAS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: CAVAL THROMBOSIS. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. IVC OCCLUSION/ THROMBOSIS, NEW DVT, IVC STENOSIS AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VENA CAVA OCCLUSION OR THROMBOSIS, VENA CAVA STENOSIS, DEEP VEIN THROMBOSIS. 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: 'IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2015". ADDITIONAL INFORMATION RECEIVED ON 30AUG2019: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2015 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DVT (DEEP VEIN THROMBOSIS) AND PE (PULMONARY EMBOLISM). PATIENT IS ALLEGING CAVAL THROMBOSIS. PER AN ATTEMPTED RETRIEVAL REPORT, "LARGE THROMBUS AT THE LEVEL OF THE IVC FILTER" "THE BENTSON WIRE HAD DIFFICULTY TRAVERSING THE FILTER, AS DID A SOFT-ANGLED GLIDEWIRE. THE GLIDEWIRE WAS EVENTUALLY POSITIONED BELLOWED THE FILTER, OVER WHICH THE STRAIGHT FLUSH CATHETER WAS PLACED. A LIMITED CONTRAST INJECTION DEMONSTRATED A LARGE AMOUNT OF THROMBUS AT THE LEVEL OF THE IVC FILTER. FILTER RETRIEVAL WAS DEFERRED AT THIS TIME AND A DISCUSSION WAS HAD WITH [DOCTOR] REGARDING FINDINGS. (B)(6) 2015, IMPLANT REPORT: "ANGIOGRAPHIC CATHETER EXCHANGED FOR A DELIVERY SHEATH FOR THE TULIP FILTER WHICH WAS DEPLOYED IN THE INFRARENAL IVC WITHOUT DIFFICULTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874554 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1