BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9990383 · Received April 23, 2020

    Report

    Report Number
    1820334-2020-00861
    Event Type
    Injury
    Date Received
    April 23, 2020
    Report Date
    May 10, 2023
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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: A2, A4, B5, B6, B7, H6. D6 INVESTIGATION INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN PERFORATION, TILT, DEPRESSION, ANXIETY AND DISCOMFORT. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE ADDITIONAL INFORMATION REGARDING ORGAN PERFORATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION RESULTS FOR VENA CAVA 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 DEPRESSION, ANXIETY AND DISCOMFORT ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. CATALOG AND LOT NUMBERS ARE UNKNOWN. THE ALLEGED TULIP IS MANUFACTURED AND INSPECTED ACCORDING TO 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. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. PER QUALITY ENGINEERING REVIEW, THE ADDITIONAL INFORMATION PROVIDED FOR THIS COMPLAINT DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION. THEREFORE, NO NEW INVESTIGATION ACTIVITIES WILL BE CONDUCTED AT THIS TIME. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. CATALOG AND LOT NUMBER ARE UNKNOWN, HOWEVER, THE ALLEGED TULIP 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

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2006 VIA THE RIGHT FEMORAL VEIN. PATIENT ALLEGES TILT, VENA CAVA PERFORATION AND EMBEDMENT. PATIENT FURTHER ALLEGES ABDOMINAL PAIN, DEPRESSION, ANXIETY AND DISCOMFORT. REPORT FROM COMPUTERIZED TOMOGRAPHY (CT)2: "IVC FILTER" "SOME OF THE FILTER STRUTS HAVE PENETRATED THROUGH THE WALL OF THE IVC INTO THE PERICAVAL/MESENTERIC FAT. THE FILTER IS TILTED ANTERIORLY WITH ITS PROXIMAL CONE LYING ON THE WALL OF THE IVC POSSIBLY EMBEDDED IN IT. SEE AXIAL IMAGE 173/476.

    Description of Event or Problem · 0

    PER COMPUTED TOMOGRAPHY REPORT, "FILTER POSITION: BELOW THE RENAL VEINS." "FILTER TILT: YES, SEE IMPRESSIONS." "FILTER PENETRATION: YES, SEE IMPRESSIONS." "IMPRESSIONS: SOME OF THE FILTER STRUTS HAVE PENETRATED THROUGH THE WALL OF THE IVC INTO THE PERICAVAL/MESENTERIC FAT. SEE AXIAL IMAGE 54 AND 56/112. THE FILTER IS TILTED ANTERIORLY WITH ITS PROXIMAL CONE LYING ON THE WALL OF THE IVC POSSIBLY EMBEDDED IN IT. SEE AXIAL IMAGE 173/476." "THE ANTERIOR STRUT PENETRATES 4 MM THROUGH THE IVC WALL. AXIAL IMAGE 224. THE LEFT STRUT PENETRATES 8 MM THROUGH THE IVC WALL. AXIAL IMAGE 221. THE POSTERIOR STRUT PENETRATES 5 MM THROUGH THE IVC WALL. AXIAL IMAGE 219. THE RIGHT STRUT PENETRATES 3 MM THROUGH THE IVC WALL. AXIAL IMAGE 221."

    Additional Manufacturer Narrative · 1

    REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION: THE REPORTED ALLEGATIONS HAVE BEEN INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA PERFORATION, EMBEDMENT, AND DISFIGURING INJURIES (PAIN/DISTRESS/LIMITED 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: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. UNKNOWN IF THE REPORTED DISFIGURING INJURIES (PAIN/DISTRESS/LIMITED ACTIVITY) ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. CATALOG AND LOT# ARE UNKNOWN. THE ALLEGED TULIP 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP ON (B)(6) 2006 AFTER A HISTORY OF PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE PATIENT'S ABDOMEN AND PELVIS THAT WAS PERFORMED APPROXIMATELY 11 YEARS AND 3 MONTHS AFTER RECEIVING THE FILTER IMPLANT REVEALED THE FILTER STRUTS HAD MOVED SINCE THE FILTER WAS PLACED, WITH SEVERAL OF THE STRUTS EXTENDING OUTSIDE [THE PATIENT'S] INFERIOR VENA CAVA AND WAS LIKELY EMBEDDED IN [THE PATIENT'S] INFERIOR VENA CAVA. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED "SIGNIFICANT, DISFIGURING INJURIES, INCLUDING SIGNIFICANT PAIN AND DISTRESS RESTRICTING[THE PATIENT'S] ABILITY TO ENGAGE IN ACTIVITIES OF DAILY LIVING." HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453775 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening