BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 11001983 · Received December 14, 2020

    Report

    Report Number
    3002808486-2020-01142
    Event Type
    Injury
    Date Received
    December 14, 2020
    Report Date
    December 14, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF#(B)(4). REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) K171217. SUMMARY OF INVESTIGATIONAL FINDINGS: THE REPORTED ALLEGATIONS HAVE BEEN 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. 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT PLATINUM FILTER ON (B)(6) 2014 VIA THE RIGHT FEMORAL VEIN. IT IS ALLEGED THAT THE [PT] EXPERIENCED PERFORATION." (B)(6) 2014, IMPLANT OP REPORT: "A COOK CELECT FILTER WAS THEN TAKEN AND POSITIONED APPROPRIATELY BELOW THE BODY OF L2, OVER THE BODY OF L3, AND DEPLOYED. A IT WAS SEEN TO BE IN GOOD POSITION. POST-PLACEMENT VENOGRAM WAS OBTAINED, WHICH DEMONSTRATED GOOD PLACEMENT OF THE VENA CAVA." (B)(6) 2018, COMPUTERIZED TOMOGRAPHY (PERFORATION): "AN INFRARENAL IVC FILTER IS IN PLACE. THE STRUTS OF THE IVC FILTER EXTEND BEYOND THE LUMEN OF THE IVC. ONE STRUT EXTENDS ALONG THE RIGHT ANTEROLATERAL ASPECT OF THE AORTA WITHOUT EVIDENCE OF PERFORATION. ONE STRUTS EXTEND INTO THE RIGHT PSOAS MUSCLE. A FEW MESENTERIC VESSELS EXTENDING IN CLOS PROXIMITY TO THE ANTERIOR STRUTS." "AN INFRARENAL IVC FILTER IS IN PLACE. THE STRUTS OF THE FILTER EXTEND BEYOND THE LUMEN OF THE IVC, AS ABOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468640 COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34502 E3222016 10827002345024

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening