BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERIDIAN FILTER SYSTEM

    MDR report key: 4262465 · Received November 14, 2014

    Report

    Report Number
    2020394-2014-00507
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    January 16, 2013
    Report Date
    October 17, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K102511
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION IS LOT NUMBER UNK. THE DEVICE WAS NOT RETURNED FOR EVALUATION OR IMAGES PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED EVENT; THEREFORE, BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT ACCUSE FOR THIS EVENT IS UNK.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE LOT MET ALL RELEASE CRITERIA.VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED.FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED.IMAGE/PHOTO REVIEW: BASED ON THE IMAGES PROVIDED, A VENA CAVA FILTER WAS DEPLOYED IN AN UPRIGHT POSITION IN THE IVC AND THE FILTER APEX IS LOCATED AT THE BASE OF L2 THE LUMBAR SPINE, CAN BE CONFIRMED.CONCLUSION: THE IMAGES IDENTIFY A DEPLOYED VENA CAVA FILTER IN AN UPRIGHT POSITION WITH THE APEX AT THE BASE OF THE L2. THE MEDICAL RECORDS ALLEGE A MERIDIAN FILTER WAS IMPLANTED SUCCESSFULLY. THE PATIENT EXPIRED APPROXIMATELY THREE MONTHS AFTER IMPLANTATION. THE CAUSE OF DEATH WAS REPORTEDLY MYOCARDIAL INFARCTION, CORONARY ARTERY DISEASE, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THERE WAS NO ALLEGED PULMONARY EMBOLISM OR FILTER DEFECT. AS NEITHER THE IMAGES NOR MEDICAL RECORDS INDICATE A FILTER FAILURE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED EVENT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN.LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: PROCEDURES REQUIRING PERCUTANEOUS INTERVENTIONAL TECHNIQUES SHOULD NOT BE ATTEMPTED BY PHYSICIANS UNFAMILIAR WITH THE POSSIBLE COMPLICATIONS. COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: - ACUTE OR RECURRENT PULMONARY EMBOLISM. THIS HAS BEEN REPORTED DESPITE FILTER USAGE. IT IS NOT KNOWN IF THROMBI PASSED THROUGH THE FILTER, OR ORIGINATED FROM SUPERIOR OR COLLATERAL VESSELS.

    Additional Manufacturer Narrative · 1

    RECEIVED MEDICAL RECORDS, MANUFACTURE INVESTIGATION CURRENTLY UNDERWAY. PATIENT PRESENTED WITH COMPLAINT OF SHORTNESS OF BREATH, COUGH, AND CHEST CONGESTION FOR APPROXIMATELY 2-3 WEEKS. A CT SCAN OF THE CHEST DEMONSTRATED PULMONARY EMBOLISM. EKG DEMONSTRATED T-WAVE ABNORMALITY PRESENT, CONSIDER ANTERIOR ISCHEMIA. ON (B)(6) 2012 A VENA CAVA FILTER WAS DEPLOYED FOR RECURRENT PULMONARY EMBOLISM, CONFIRMED BY CT SCAN. FILTER WAS DEPLOYED SUCCESSFULLY INFERIOR TO THE RENAL TAKEOFFS IN AN UPRIGHT POSITION. EIGHT DAYS POST FILTER DEPLOYMENT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF ABDOMINAL PAIN. CT SCAN PERFORMED DEMONSTRATED ACUTE APPENDICITIS. THE NEXT DAY SURGERY WAS PERFORMED FOR ACUTE APPENDICITIS AND UMBILICAL HERNIA. FIVE DAYS POST HOSPITAL ADMISSION THE PATIENT WAS DISCHARGED IN STABLE CONDITION. (B)(6) 2013 EMS CALLED, UPON ARRIVAL PATIENT WAS IN AGONAL PEA, HEART RHYTHM CHANGED FROM VF TO VT. EMT REPORTED NO RESPONSE TO EYE-OPENING, NO RESPONSE FOR MOTOR SKILLS, AND NO RESPONSE VERBALLY. EMT ARRIVED AT 2354 CPR WAS PERFORMED UNTIL 0024. (B)(6) 2013 DEATH CERTIFICATE: CAUSE OF DEATH WAS MYOCARDIAL INFARCTION, CORONARY ARTERY DISEASE, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. DEATH CERTIFICATE INDICATED TIME A DEATH WAS 0024 ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNK IVC FILTER WAS DEPLOYED AT SOME TIME. THE PT HAD A HISTORY OF PULMONARY SYMBOLISM. THE PT REPORTEDLY EXPIRED. DESPITE MEDICAL RESUSCITATION EFFORTS.

    Description of Event or Problem · 1

    NEW INFORMATION FROM MEDICAL RECORDS: IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST FILTER DEPLOYMENT FOR HISTORY OF PULMONARY EMBOLISM, PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT WITH SEVERE ABDOMINAL PAIN. CT IMAGING DEMONSTRATED AN ACUTE APPENDICITIS; AN EMERGENCY APPENDECTOMY AND UMBILICAL HERNIA SURGERY WAS PERFORMED. THE PATHOLOGY REPORT INDICATED THE APPENDIX CONTAINED FECAL MATERIAL. ONE MONTH POST SURGICAL APPENDECTOMY THE PATIENT WAS FOUND UNRESPONSIVE. 911 WAS CALLED, DESPITE MEDICAL RESUSCITATION EFFORTS PERFORMED BY EMT, THE PATIENT REPORTEDLY EXPIRED. THE DEATH CERTIFICATE CAUSE OF DEATH INDICATED MYOCARDIAL INFARCTION, CORONARY ARTERY DISEASE, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738894 MERIDIAN FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFWG2696

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death