ECLIPSE FILTER SYSTEM - FEMORAL

Additional Manufacturer Narrative

H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2011, A PATIENT UNDERWENT FILTER PLACEMENT VIA THE COMMON FEMORAL VEIN DUE TO PULMONARY EMBOLISM STATUS POST LEFT MICROVASCULAR DECOMPRESSION FOR REFRACTORY TRIGEMINAL NEURALGIA. APPROXIMATELY ONE MONTH AND EIGHTEEN DAYS LATER, ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS, WHICH WAS CONFIRMED BY AN ULTRASOUND. FURTHER, APPROXIMATELY THREE YEARS, EIGHT MONTHS AND TWENTY-TWO DAYS LATER, ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH CHEST PAIN, SINUS TACHYCARDIA AND ARRYTHMIA. APPROXIMATELY ONE YEAR, NINE MONTHS AND FIVE DAYS LATER, ON (B)(6) 2017, IT WAS REPORTED THAT THE FILTER HAD ALLEGEDLY FRACTURED WITH ONE STRUT MIGRATED TO THE MIDDLE LOBE OF RIGHT LUNG, WHICH WAS CONFIRMED BY A CHEST X RAY. ADDITIONALLY, APPROXIMATELY TWO YEARS, SEVEN MONTHS AND FOUR DAYS LATER, ON (B)(6) 2019, THE PATIENT EXPERIENCED COUGH AND SHORTNESS OF BREATH. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.