Device Events – Example Signal Alert Email Report

NOTE: This is an example of a typical Signal Alert Report showing the Adverse Events resulting from the search, which for this example is for IVC Filters for the month of December 2017. The report below shows the first 5 of the 132 Adverse Events resulting from the search. Each Adverse Event has a Title and a preview of the report narrative. Click on the Title to view the report details or click on the CHART icon to view the related chart.

SEARCH: ivc filter
TRAPEASE PVCF FEM/JUG 55CM CSI – Johnson & Johnson , 2017-12-02 , 7077672
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE INFERIOR VENA CAVA ( IVC FILTER . THE INDICATION FOR FILTER PLACEMENT WAS NOT REPORTED. THERE IS NO AVAILABLE INFORMATION REGARDING THE IMPLANTATION PROCEDURE. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING BUT NOT LIMITED TO, FRACTURE, MIGRATION OF ENTIRE FILTER TO HEART, PERFORATION OF FILTER STRUTS INTO VENA CAVA AND ORGANS, TILT, FILTER EMBEDDED IN WALL OF THE INFERIOR VENA CAVA ( IVC ), REQUIRING EMERGENCY OPEN-HEART SURGERY. AS A…

466FXXXX – Johnson & Johnson , 2017-12-19 , 7130208
THE EXACT IMPLANT DATE IS UNKNOWN. THE CATALOG NUMBER IS UNKNOWN, IF RECEIVED IT WILL BE PROVIDED. COMPLAINT CONCLUSION: AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER . THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, FRACTURE, EMBEDMENT OF THE FILTER TO THE WALL OF THE IVC , MIGRATION, AND MULTIPLE PERFORATIONS OF THE INFERIOR VENA CAVA ( IVC ) WALL. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING…

UNKNOWN VENA CAVA FILTER – Johnson & Johnson , 2017-12-28 , 7150639
DEVICE REMAINS IMPLANTED. AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER . APPROXIMATELY TEN YEARS POST IMPLANTATION THE PATIENT UNDERWENT AN UPDATED CT SCAN WHICH REVEALED THAT THE FILTER HAD SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, THE FILTER WAS SIGNIFICANTLY TILTED, THE FILTER HAD MIGRATED, ONE STRUT WAS BENT, ONE STRUT HAD FRACTURED, THE TIP OF THE FILTER WAS EMBEDDED IN THE ANTERIOR WALL OF THE INFERIOR VENA CAVA ( IVC ) AND AT LEAST FOUR STRUTS… IVC

466FXXXX – Johnson & Johnson , 2017-12-22 , 7141909
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER . THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, TILT, MIGRATION, AND PERFORATION OF THE FILTER STRUTS THROUGH THE INFERIOR VENA CAVA ( IVC ) WALL. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER…

466FXXXX – Johnson & Johnson , 2017-12-12 , 7108084
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF TWO OPTEASE INFERIOR VENA CAVA ( IVC FILTERS . PER THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF ACUTE DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG AND WAS ADMITTED TO THE HOSPITAL FOR WORSENING OF THE DVT WHILE ON ANTICOAGULATION. THE PATIENT HAD RECENTLY BEEN DIAGNOSED WITH COMPARTMENT SYNDROME. THE PATIENT ALSO HAD RECENTLY… , PRIOR TO THE FIRST FILTER IMPLANTATION, UNDERGONE SURGERY AND HAD FASCIOTOMY WOUNDS AND HEMATOMAS. ORIGINALLY, THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND THE