BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3960575 · Received July 16, 2014

    Report

    Report Number
    3002808486-2014-00029
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    March 19, 2014
    Report Date
    July 12, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. WILLIAM COOK (B)(4) APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REFERENCE # (B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT PROBLEM. SERIOUS INJURY TO MALFUNCTION. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT #: UNK AS INFO WAS NOT PROVIDED BUT REFERRED TO AS IVC FILTER (TULIP). EXP DATE: UNK AS LOT # IS UNK. UNK AS LOT # IS UNK. SUMMARY OF INVESTIGATION FINDINGS: RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO DEVICE, IMAGING STUDIES OR COMPLETE HOSP OR MEDICAL RECORDS HAVE BEEN PROVIDED. CONSEQUENTLY, BASED ON VERY LIMITED INFO IT IS DIFFICULT TO COMMENT ON THE ALLEGED FILTER PERFORATION AND DIFFICULT FILTER REMOVAL AND STENOSIS. DIFFICULT REMOVAL OF VENA CAVA FILTERS HAS BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE ALLEGED DIFFICULT FILTER REMOVAL CANNOT BE DETERMINED BASED ON THE LIMITED INFO PROVIDED. MONITORING OF SIMILAR REPORTS WILL CONTINUE.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 02/09/2017 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT FEMORAL VEIN DUE TO DVT. PLAINTIFF ALLEGES THERE WAS AN ATTEMPTED RETRIEVAL ON (B)(6) 2012 VIA THE INTERNAL JUGULAR. CT SCAN NOTED THAT THE IVC FILTER HAS TIP ADJACENT TO THE L1 VERTEBRAL BODY. PLAINTIFF IS ALLEGING VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED, OTHER: LIFETIME ANTICOAGULATION.

    Description of Event or Problem · 1

    ALLEGATIONS ACCORDING TO COMPLAINANT: ON (B)(6) 2014, THE PT UNDERWENT A RIGHT ULTRASOUND-GUIDED INTERNAL JUGULAR VEIN PUNCTURE, VENOGRAM, ANGIOPLASTY OF INFERIOR VENA CAVA USING 60MM ANGIOPLASTY BALLOON, AND ATTEMPTED INFERIOR VENA CAVA FILTER REMOVAL. THE IVC WAS PATENT TO THE LEVEL OF THE FILTER. JUST PROXIMAL TO THE FILTER, THERE AS A HIGH-=GRADE STENOSIS OF THE IVC. IT WAS UNCLEAR WHETHER THIS WAS RELATED TO THE FILTER PLACEMENT OR NOT. A SNARE WAS PLACED AND MULTIPLE ATTEMPTS TO SNARE THE HOOK ON THE IVC FILTER WERE PERFORMED. THE PHYSICIAN WAS UNABLE TO SNARE THE HOOK ON THE IVC FILTER. DUE TO THE STENOSIS, THE PHYSICIAN WAS CONCERNED ABOUT LEAVING THE FILTER IN THE PT. THEY WERE ABLE TO GRASP THE FILTER, BUT UNFORTUNATELY, DUE TO ONE OF THE STRUTS BEING BENT UPON INSERTION, THEY WERE UNABLE TO REMOVE THE FILTER. THE PHYSICIAN WAS ABLE TO CAPTURE MOST OF THE FILTER, BUT COULD NOT GET THE FINAL STRUT TO COLLAPSE INTO THE SHEATH. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN VENOGRAPHICALLY CONFIRMED THAT THE CAVA WAS STILL PATENT AND NO FURTHER DEFECTS WERE APPRECIATED. THE STENOSIS PROXIMAL TO THE FILTER WAS STILL PRESENT. THE PHYSICIAN DID NOT FEEL LIKE THERE WAS AN ENDOVASCULAR WAY TO SAFELY REMOVE THE FILTER AT THAT TIME. THE PT WAS TAKEN TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415931 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| O