BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9716499 · Received February 17, 2020

    Report

    Report Number
    3002808486-2020-00211
    Event Type
    Injury
    Date Received
    February 17, 2020
    Report Date
    March 27, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6 DEVICE CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (3191) WAS SELECTED FOR THE ALLEGED DEVICE PERFORATION. INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA (VC)/ARTERY PERFORATION, FILTER THROMBUS/OCCLUSION, CLAUDICATION, DEEP VEIN THROMBOSIS (DVT), LEG/BACK PAIN, LEG BLISTERS, NEED OF COMPRESSION SOCKS, PHYSICAL LIMITATIONS. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. 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. UNKNOWN IF THE REPORTED LEG/BACK PAIN, LEG BLISTERS, NEED OF COMPRESSION SOCKS, AND PHYSICAL LIMITATIONS ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN; HOWEVER, THERE IS 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. 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. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT), FOLLOWED BY A SUCCESSFUL RETRIEVAL ON (B)(6) 2017. PATIENT IS ALLEGING VENA CAVA PERFORATION AND THROMBUS IN FILTER. THE PATIENT FURTHER ALLEGES "THROMBUS IN FILTER, PAIN IN LEGS AND BACK, BLISTERS ON LEGS, NEEDING COMPRESSION SOCKS CONTINUOUSLY, CAN'T WALK OR STAND FOR MORE THAN 30 MINUTES WITHOUT PAIN, STRUT PERFORATION OF THE INFERIOR VENA CAVA; THROMBUS WITHIN THE IVC FILTER, OCCLUSION OF FILTER, REPEAT DVTS, SEVERE VENOUS CLAUDIFICATION [SIC]." REPORT FROM CT (COMPUTED TOMOGRAPHY): "VENOUS STRUCTURES: AN INFERIOR VENA CAVA FILTER IS IN PLACE. THE FILTER IS LOCATED IN THE MID TO INFERIOR ASPECT OF THE IVC. THE CEPHALAD TIP OF THAT IS APPROXIMATE 4 CM INFERIOR TO THE LEVEL OF THE LOWEST MOST (LEFT) RENAL VEIN. THERE IS EVIDENCE OF STRUT PERFORATION OF THE INFERIOR VENA CAVA. THERE IS DECREASED DENSITY WITHIN THE CENTRAL ASPECT OF THE IVC FILTER THAT MAY REPRESENT THROMBUS. "AN IVC FILTER IS IN PLACE. THERE IS EVIDENCE OF STRUT PERFORATION OF THE IVC AS DISCUSSED. THERE IS PROBABLY A SMALL AMOUNT OF THROMBUS WITHIN THE FILTER." "THE COMMON ILIAC VEINS ARE VERY SMALL IN CALIBER BILATERALLY." "THERE IS REDEMONSTRATION OF THROMBUS IN THE LEFT EXTERNAL ILIAC VEIN, LEFT COMMON FEMORAL VEIN, CENTRAL LEFT SAPHENOUS VEIN, AND CENTRAL LEFT DEEP FEMORAL VEIN." "A SMALL AMOUNT OF THROMBUS IS SEEN CENTRALLY WITHIN THE LEFT OVARIAN VEIN." RETRIEVAL REPORT (SUCCESSFUL): "THIS CHANGED THE CONFORMATION OF THE TIP OR CONE OF THE FILTER WHICH ALLOWED [DOCTOR] TO CAPTURE IT. AT THIS POINT AFTER [DOCTOR] WAS DONE, AN ARTERIOGRAM WAS PERFORMED WHICH SHOWED NO EVIDENCE OF EXTRAVASATION IN THE RIGHT COMMON ILIAC ARTERY WHERE THERE HAD PREVIOUSLY BEEN A STRUT OF THE FILTER."

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING 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 CELECT FILTER ON (B)(6) 2012. IT IS ALLEGED THAT THE [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
    181038 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening