BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 9154865 · Received October 4, 2019

    Report

    Report Number
    3002808486-2019-01621
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Report Date
    November 14, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K121629
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (3191) WAS SELECTED FOR THE ALLEGED DEVICE TILT. 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. EMBEDDED, TILT, DYSPNEA, ANXIETY, STICKING SENSATION IN CHEST, POST OP DISCOMFORT AND SCARS. 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. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. UNKNOWN IF THE REPORTED DYSPNEA, ANXIETY, STICKING SENSATION IN CHEST, POST OP DISCOMFORT AND SCARS ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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 BECOMES 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) 2017 VIA RIGHT COMMON FEMORAL VEIN DUE TO PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING TILT AND EMBEDMENT. THE PATIENT FURTHER ALLEGES ¿ANXIETY, SHORTNESS OF BREATH AND A STICKY FEELING IN UPPER CHEST AREA AND SOME DISCOMFORT IN THE AREA WHERE THE FILTER WAS PULLED OUT AND SCARS ARE VISIBLE.¿ PER A CT (COMPUTED TOMOGRAPHY) SCAN OF THE ABDOMEN DATED (B)(6) 2017, ¿IVC FILTER ¿ WITH MILD ANGULATION.¿ PER AN IR INFERIOR VENA CAVA REMOVAL ATTEMPT OPERATIVE REPORT DATED (B)(6) 2017, ¿NO EVIDENCE OF INFERIOR VENA CAVA THROMBUS. UNSUCCESSFUL ATTEMPT AT FILTER RETRIEVAL AND REMOVAL.¿ PER AN IR INFERIOR VENA CAVA REMOVAL ATTEMPT OPERATIVE REPORT DATED (B)(6) 2017, ¿SUCCESSFUL IMAGE GUIDED PERCUTANEOUS RETRIEVAL OF IVC FILTER AFTER VENOGRAPHIC CONFIRMATION OF ABSENCE OF SIGNIFICANT CAVAL CLOT.¿

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT PLATINUM FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) K171712. 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

    'IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT PLATINUM FILTER ON (B)(6) 2017". 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
    952448 COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3570821

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening