BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 14443721 · Received May 19, 2022

    Report

    Report Number
    3002808486-2022-00344
    Event Type
    Injury
    Date Received
    May 19, 2022
    Report Date
    December 8, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INITIAL REPORTER NAME AND ADDRESS: CUSTOMER (PERSON) NOT PROVIDED, INFORMATION PROVIDED BY (B)(6). OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) #: K211875. INVESTIGATION: 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. RPN/LOT IS UNKNOWN, HOWEVER, THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO CURRENT CONTROLS. 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. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. G4 (510K): K211875. 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) PERFORATION, TILT, ANXIETY, WORRY, FEAR, LIMITED PHYSICAL ACTIVITY. 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: 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. UNKNOWN IF THE REPORTED ANXIETY, WORRY, FEAR, AND LIMITED PHYSICAL ACTIVITY ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 20 DEVICES IN LOT. NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THE LOT. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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 REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED A COOK CELECT PT FILTER ON (B)(6)2016 VIA THE RIGHT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING ANXIETY, WORRY, FEAR, AND LIMITED PHYSICAL ACTIVITY. PER A COMPUTED TOMOGRAPHY (CT) ABDOMEN/PELVIS: "COOK CELECT PLATINUM FILTER. CAVAL PERFORATION: YES. 11 O'CLOCK 3.80MM GRADE 2. TILT: YES. LEFT-SIDED TILT MEASURING 14.36 DEGREES. MIGRATION: NO. PERTINENT NEGATIVES: NONE. ADDITIONAL FINDINGS: NONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319675 COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34502 E3418541 10827002345024

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening