BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 3145609 · Received June 4, 2013

    Report

    Report Number
    9616099-2013-00343
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    July 1, 2005
    Report Date
    May 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HUSSAIN ET AL SUPERIOR VENA CAVA PERFORATION AND CARDIAC TAMPONADE AFTER FILTER PLACEMENT IN THE SUPERIOR VENA CAVA: A CASE REPORT.; VASC ENDOVASC SURG. 2005; 39(4):367-370, REPORTS THE COMPLICATION OF PERFORATION OF THE SUPERIOR VENA CAVA (SVC) LEADING TO CARDIAC TAMPONADE AFTER THE INSERTION OF A TRAPEASE IVC FILTER IN THE SVC POSITION. A (B)(6) MAN WAS HIT BY A MOTOR VEHICLE AND SUSTAINED NUMEROUS INJURIES INCLUDING A LEFT SKULL FRACTURE, INTRACEREBRAL HEMORRHAGE, AND LEFT OPEN TIBIAL SHAFT FRACTURE. DURING HIS HOSPITALIZATION, HE DEVELOPED AN EXTENSIVE SYMPTOMATIC RIGHT UPPER EXTREMITY DEEP VENOUS THROMBOSIS INVOLVING THE BRACHIAL, AXILLARY, SUBCLAVIAN, INTERNAL JUGULAR, AND BRACHIOCEPHALIC VEINS. OWING TO AN INTRACEREBRAL BLEED, ANTICOAGULATION WAS CONTRAINDICATED. THEREFORE, A TRAPEASE FILTER (CORDIS INC.) WAS PLACED IN THE SVC VIA THE LEFT SUBCLAVIAN VEIN. FOUR HOURS LATER, THE PATIENT BECAME HYPOTENSIVE WITH ASSOCIATED TACHYCARDIA AND TACHYPNEA. COMPUTED TOMOGRAPHY OF HIS CHEST REVEALED A HEMATOMA AROUND THE SVC, A MODERATE AMOUNT OF FLUID WITHIN THE PERICARDIUM, AND A MODERATE-SIZED RIGHT PLEURAL EFFUSION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A PERICARDIAL WINDOW WAS PERFORMED. APPROXIMATELY 500 CC OF BLOOD WAS EVACUATED FROM THE PERICARDIUM AND IMMEDIATE IMPROVEMENT IN VITAL SIGNS WAS NOTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 WEEKS LATER AND AT 6-MONTH FOLLOW-UP HAD MADE A FULL RECOVERY. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE IFU LISTS PERFORATION OF THE VESSEL WALL AND INTIMAL TEAR AS POSSIBLE PROCEDURE COMPLICATIONS. BASED ON THE LIMITED PROCEDURAL INFORMATION PROVIDED REGARDING FILTER PLACEMENT, IT IS NOT POSSIBLE TO DETERMINE WHAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS REPORTED. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE IS THE DATE OF PUBLICATION. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: HUSSAIN ET AL SUPERIOR VENA CAVA PERFORATION AND CARDIAC TAMPONADE AFTER FILTER PLACEMENT IN THE SUPERIOR VENA CAVA: A CASE REPORT.; VASC ENDOVASC SURG. 2005; 39(4):367-370. THE ARTICLE REPORTED THE COMPLICATION OF PERFORATION OF THE SUPERIOR VENA CAVA (SVC) LEADING TO CARDIAC TAMPONADE AFTER THE INSERTION OF A TRAPEASE IVC FILTER IN THE SVC POSITION. A MAN WAS HIT BY A MOTOR VEHICLE AND SUSTAINED NUMEROUS INJURIES INCLUDING A LEFT SKULL FRACTURE, INTRACEREBRAL HEMORRHAGE, AND LEFT OPEN TIBIAL SHAFT FRACTURE. DURING HIS HOSPITALIZATION, HE DEVELOPED AN EXTENSIVE SYMPTOMATIC RIGHT UPPER EXTREMITY DEEP VENOUS THROMBOSIS INVOLVING THE BRACHIAL, AXILLARY, SUBCLAVIAN, INTERNAL JUGULAR, AND BRACHIOCEPHALIC VEINS. OWING TO AN INTRACEREBRAL BLEED, ANTICOAGULATION WAS CONTRAINDICATED. THEREFORE, A TRAPEASE FILTER (CORDIS INC.) WAS PLACED IN THE SVC VIA THE LEFT SUBCLAVIAN VEIN. FOUR HOURS LATER, THE PATIENT BECAME HYPOTENSIVE WITH ASSOCIATED TACHYCARDIA AND TACHYPNEA. COMPUTED TOMOGRAPHY OF HIS CHEST REVEALED A HEMATOMA AROUND THE SVC, A MODERATE AMOUNT OF FLUID WITHIN THE PERICARDIUM, AND A MODERATE-SIZED RIGHT PLEURAL EFFUSION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A PERICARDIAL WINDOW WAS PERFORMED. APPROXIMATELY 500 CC OF BLOOD WAS EVACUATED FROM THE PERICARDIUM AND IMMEDIATE IMPROVEMENT IN VITAL SIGNS WAS NOTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 WEEKS LATER AND AT 6-MONTH FOLLOW-UP HAD MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245978 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L| R