BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT JUGULAR VENA CAVA FILTER SET

    MDR report key: 14444663 · Received May 19, 2022

    Report

    Report Number
    3002808486-2022-00638
    Event Type
    Injury
    Date Received
    May 19, 2022
    Report Date
    September 29, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002483729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 510(K) #: K211874. 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. THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: B5, D1, D4, ANNEX G, ANNEX B, ANNEX C, ANNEX D, AND H6. CORRECTED DATA: D1 AND D4. INVESTIGATION: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN PERFORATION. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. 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. 20 DEVICES IN LOT. NO RELEVANT NOTES ON WORK ORDER. THE PRODUCT 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 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: 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 PERFORATION, TILT, ANXIETY, WORRY, FEAR, LIMITED PHYSICAL ACTIVITY. THE ADDITIONAL INFORMATION REGARDING VENA CAVA PERFORATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION RESULTS FOR ORGAN PERFORATION. 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 ANXIETY, WORRY, FEAR, LIMITED PHYSICAL ACTIVITY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 20 DEVICES IN LOT. THE PRODUCT 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 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

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS IMPLANTED WITH A CELECT FILTER.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, AND ORGAN ABUTMENT. THE PATIENT FURTHER ALLEGES ANXIETY, WORRY, FEAR, AND LIMITED PHYSICAL ACTIVITY. REPORT FROM CT (COMPUTED TOMOGRAPHY): "CAVAL PERFORATION: YES. GRADE 3 PERFORATION OF THE 3 O'CLOCK LEG TO ABUT THE AORTA. GRADE 3 PERFORATION OF 6 O'CLOCK LEG TO ABUT ANTERIOR OSTEOPHYTE AT L4. GRADE 2 PERFORATION OF 12 O'CLOCK LEG 0.55CM. TILT: 16.38 DEGREES OF SAGITTAL TILT. NO SUBSTANTIAL CORONAL TILT. APEX OF FILTER EXTENDS 0.20CM BEYOND THE POSTERIOR WALL OF IVC. MIGRATION: NO. PERTINENT NEGATIVES: NO DEFINITE FRACTURE OR MISSING STRUTS. NO IVC STENOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752173 COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G48372 E3011620 00827002483729

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening