BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 11284157 · Received February 5, 2021

    Report

    Report Number
    3002808486-2021-00100
    Event Type
    Injury
    Date Received
    February 5, 2021
    Report Date
    June 8, 2021
    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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: A2, A4, B1, B2, B5, B6, B7, D1, D4, D8, G4, G5, H4, ANNEX E, ANNEX F, ANNEX A, ANNEX B, ANNEX C, ANNEX D, AND H6. G4: K172557 INVESTIGATION THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN/VENA CAVA PERFORATION, TILT, STOMACH SWELLING, LIMITED MOBILITY, ANXIETY. 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, 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 STOMACH SWELLING, LIMITED MOBILITY, ANXIETY ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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.

    Description of Event or Problem · 0

    THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2016 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS. THE PATIENT ALLEGES TILT AND VENA CAVA PERFORATION. THE PATIENT FURTHER ALLEGES "MILD TILTING TO THE LEFT LATERAL POSTERIOR DIRECTION, PERFORATION OF ALL FOUR PRONGS, TWO HAVE MESENTERIC PERFORATION, ONE POSSIBLY PERFORATES THE AORTIC WALL, SWELLING IN STOMACH", LIMITED MOBILITY, AND ANXIETY. (B)(6) 2019, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿IVC FILTER: THERE IS MILD TILTING OF THE IVC FILTER TO THE LEFT LATERAL POSTERIOR DIRECTION. THE FILTER APEX IS NOT ABUTTING THE IVC WALL. SUPERIOR TIP OF THE FILTER IS AT L2-L3 DISC LEVEL WITH THE INFERIOR TIPS AT THE SUPERIOR MARGIN OF THE L4 BODY. THE RIGHT RENAL VEIN IS SLIGHTLY INFERIOR IN LOCATION COMPARED TO LEFT. THE INFERIOR TIP IS JUST BELOW THE LEVEL OF THE RIGHT RENAL VEIN. FOUR PRONGS/STRUTS OF THE FILTER ARE NOTED, ORIENTED IN A 12:30, 3:30, 6:30 AND 9:30 O¿CLOCK DIRECTIONS. NOTE IS MADE OF PERFORATION OF ALL OF THE 4 PRONGS OF THE ONE OF THE IVC THE FOUND AT 1230 LOCATION DEMONSTRATES MESENTERY PERFORATION, APPROXIMATELY 0.3CM FROM THE ANTERIOR WALL. A PRONG AT 3:30 LOCATION CLOSELY ABUTS THE ADJACENT AORTIC WALL; IT IS DIFFICULT TO DETERMINE WHETHER IT IS FOR A PERFORATING INTO THE AORTIC WALL. A PRONG AT 6:30 LOCATION PERFORATES THE POSTERIOR WALL AND TERMINATE 0.5CM A FROM THE WALL. THERE IS AN EXCESSIVE THE RIGHT RENAL VEIN, APPROXIMATELY 1CM BELOW THE MAIN RIGHT RENAL VEIN, COURSING INFERIORLY DRAINING THE LOWER POLE OF THE RIGHT KIDNEY. THERE IS MESENTERIC PERFORATION OF THE PRONG LOCATED AT 9:30 LOCATION WHICH TERMINATES, 0.6 CM AWAY FROM THE RIGHT LATERAL WALL OF THE IVC. THERE IS NO EVIDENCE OF FRACTURE OR BENDING OF STRUTS. THERE IS NO EVIDENCE OF STENOSIS OF THE IVC.¿

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) K172557. 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 GUNTHER TULIP FILTER ON (B)(6) 2016. 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
    182740 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3374240

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening