BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 4872312 · Received June 26, 2015

    Report

    Report Number
    9616099-2015-00253
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    October 1, 2013
    Report Date
    June 5, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUED: HER PHYSICIANS DECIDED THAT SHE WOULD BENEFIT FROM A PERMANENT VCF. A TRAPEASE FILTER WAS SUBSEQUENTLY PLACED IN THE INFRARENAL SEGMENT OF HER IVC, EXTENDING ACROSS THE L3-L4 VERTEBRAL INTERSPACE. ONCE THE HEMATOMA HAD RESOLVED, ANTICOAGULATION THERAPY WAS CONTINUED WITH DAILY INJECTIONS OF LOW-MOLECULAR-WEIGHT HEPARIN (LMWH). BECAUSE OF HER HISTORY OF VENOUS THROMBOEMBOLIC DISEASE, AT THE AGE OF (B)(6), SHE WAS EVALUATED BY A VASCULAR SPECIALIST. A THOROUGH EVALUATION WAS NEGATIVE FOR THE DEFINITIVE DIAGNOSIS OF A THROMBOPHILIA CONDITION, AND SHE WAS CONSIDERED TO HAVE AN UNDEFINED HYPERCOAGULABLE STATE FOR WHICH CONTINUATION OF LONGTERM ANTICOAGULATION THERAPY WAS RECOMMENDED. COMPUTER TOMOGRAPHIC SCAN OF THE ABDOMEN REVEALED CHRONIC PERFORATION OF THE IVC BY THE VERTICAL STRUTS AND BARBS OF THE TRAPEASE FILTER. GIVEN HER ASYMPTOMATIC STATUS, FILTER REMOVAL WAS NOT RECOMMENDED. SHE REPORTED THAT SHE WAS ADVISED THAT NO EXPERIENCE EXISTED TO INDICATE THAT PREGNANCY COULD NOT BE SAFELY ATTEMPTED AS LONG AS ANTICOAGULATION WAS CONTINUED. SEVEN MONTHS LATER, SHE BECAME PREGNANT. AT 24 WEEKS, 2 DAYS GESTATION, IMMEDIATELY FOLLOWING MISSIONARY-POSITION COITUS, SHE EXPERIENCED ACUTE ONSET OF DIFFUSE ABDOMINAL PAIN, BACK PAIN, AND DYSPNEA. ON PHYSICAL EXAMINATION, HER INITIAL BLOOD PRESSURE WAS 115/66 MM HG WITH A HEART RATE OF 152. HER ABDOMEN WAS DIFFUSELY TENDER. GIVEN HER PREVIOUS HISTORY OF PE AND HER COMPLAINTS OF DYSPNEA, PULMONARY COMPUTED TOMOGRAPHIC ANGIOGRAPHY WAS PERFORMED. NO PE WAS FOUND, BUT FREE INTRAPERITONEAL FLUID WAS NOTED. IMMEDIATELY FOLLOWING THE COMPUTED TOMOGRAPHIC ANGIOGRAPHY, HER HEMODYNAMICS DECLINED WITH A CORRESPONDING DECREASE IN FETAL HEART RATE. SHE WAS TAKEN EMERGENTLY TO THE LABOR AND DELIVERY OPERATING ROOM BY THE OBSTETRICAL TEAM FOR CAESAREAN SECTION AND ABDOMINAL EXPLORATION. UPON CELIOTOMY THROUGH A VERTICAL MIDLINE INCISION, AT LEAST 2.5 LITERS OF FREE INTRAPERITONEAL BLOOD WERE ENCOUNTERED. THE FETUS WAS DELIVERED BUT WAS UNABLE TO BE RESUSCITATED AND DIED SHORTLY AFTER BIRTH. UTERINE ATONY WAS ENCOUNTERED AND TREATED WITH INTRAMUSCULAR METHERGINE. A GROUP OF SMALL VERTICAL LACERATIONS, ACTIVELY BLEEDING, WERE NOTED IN THE POSTERIOR WALL OF THE UTERINE DOME, AND THESE WERE REPAIRED WITH ABSORBABLE SUTURE. A TEAR IN THE PERITONEAL MEMBRANE OVERLYING THE FILTER-BEARING IVC WAS PRESENT, WITH FREELY EXPOSED SHARP BARBS AND VERTICAL STRUTS OF THE VCF (FIG 2). THESE STRUTS WERE IN PROXIMITY TO THE UTERINE LACERATIONS. ANTERIORLY, THE EXPOSED STRUTS WERE REMOVED USING WIRE CUTTERS. THE IVC AND RETROPERITONEUM WERE THOROUGHLY INSPECTED. THERE WAS NO RETROPERITONEAL HEMATOMA TO SUGGEST THAT THE INITIAL SOURCE OF BLEEDING HAD ORIGINATED FROM A RETROPERITONEAL STRUCTURE, AND THE IVC WAS FIBROSED IN THE REGION OF THE FILTER. THERE WAS A VERY SMALL AREA OF ADVENTITIAL TRAUMA IN THE REGION OF AN EXTRUDED STRUT, BUT THERE WAS NO EVIDENCE TO INDICATE THIS WAS THE SOURCE OF HER INTRAPERITONEAL HEMORRHAGE. THIS WAS TREATED WITH A SINGLE PROLENE SUTURE. THE REMAINING ELEMENTS OF THE FILTER WERE SECURED WITH TWO ADDITIONAL PROLENE SUTURES TO PREVENT POTENTIAL MIGRATION. GIVEN HER HEMODYNAMIC INSTABILITY AND ANTICOAGULATED STATE, THE LATERAL STRUTS WERE LEFT IN PLACE, AND NO ATTEMPT WAS MADE AT MOBILIZATION OF THE POSTERIOR IVC. A VASCULARIZED, TRANSMESOCOLIC OMENTAL PEDICLE FLAP WAS PLACED AROUND THE FILTER-BEARING REGION OF THE IVC TO SEPARATE SURROUNDING STRUCTURES FROM CONTACT WITH REMAINING ELEMENTS OF THE DEVICE. THE PATIENT¿S TOTAL INPATIENT STAY WAS 13 DAYS AND WAS COMPLICATED BY INTRA-ABDOMINAL ABSCESS TREATED WITH PERCUTANEOUS DRAINAGE AND ANTIBIOTICS, IN ADDITION TO A WOUND INFECTION. SHE HAS BEEN SEEN AT REGULAR FOLLOW-UP INTERVALS (9 MONTHS TO DATE), REMAINED COMPLIANT WITH ANTICOAGULATION THERAPY, AND HAS HAD NO EPISODES OF RECURRENT VENOUS THROMBOEMBOLISM. (B)(4). THE CATALOG # OF 466P306X REPRESENTS AN UNKNOWN TRAPEASE FILTER. THE ACTUAL LOT AND CATALOG # FOR THE TRAPEASE FILTER USED IN THIS PATIENT IS UNKNOWN AT THIS TIME. THIS COMPLAINT WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: MAIJUB ET AL (2013). UTERINE TRAUMA WITH FETAL LOSS ASSOCIATED WITH CHRONIC PERFORATION OF THE INFERIOR VENA CAVA BY AN INFRARENAL VENA CAVA FILTER, JOURNAL OF VASCULAR SURGERY 1, 412-414. CONCOMITANT PRODUCTS: LONG TERM ANTICOAGULATION THERAPY WAS CONTINUED WITH DAILY INJECTIONS OF LOW-MOLECULAR-WEIGHT HEPARIN (LMWH). THE DEVICE REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY MAIJUB ET AL, UTERINE TRAUMA WITH FETAL LOSS ASSOCIATED WITH CHRONIC PERFORATION OF THE INFERIOR VENA CAVA BY AN INFRARENAL VENA CAVA FILTER, 1 (2013) 412-414: A PATIENT WITH A KNOWN HISTORY OF DEEP VENOUS THROMBOSIS, RECURRENT PULMONARY EMBOLI (PE), AND WARFARIN ALLERGY, WAS EVALUATED FOR IVC INTERRUPTION WITH A VCF DUE TO RETROPERITONEAL HEMORRHAGE COMPLICATING ANTICOAGULATION THERAPY. HER PHYSICIANS DECIDED THAT SHE WOULD BENEFIT FROM A PERMANENT VCF. A TRAPEASE FILTER WAS SUBSEQUENTLY PLACED IN THE INFRARENAL SEGMENT OF HER IVC, EXTENDING ACROSS THE L3-L4 VERTEBRAL INTERSPACE. ONCE THE HEMATOMA HAD RESOLVED, ANTICOAGULATION THERAPY WAS CONTINUED WITH DAILY INJECTIONS OF LOW-MOLECULAR-WEIGHT HEPARIN (LMWH). BECAUSE OF HER HISTORY OF VENOUS THROMBOEMBOLIC DISEASE, AT THE AGE OF (B)(6), SHE WAS EVALUATED BY A VASCULAR SPECIALIST. A THOROUGH EVALUATION WAS NEGATIVE FOR THE DEFINITIVE DIAGNOSIS OF A THROMBOPHILIA CONDITION, AND SHE WAS CONSIDERED TO HAVE AN UNDEFINED HYPERCOAGULABLE STATE FOR WHICH CONTINUATION OF LONGTERM ANTICOAGULATION THERAPY WAS RECOMMENDED. COMPUTER TOMOGRAPHIC SCAN OF THE ABDOMEN REVEALED CHRONIC PERFORATION OF THE IVC BY THE VERTICAL STRUTS AND BARBS OF THE TRAPEASE FILTER. GIVEN HER ASYMPTOMATIC STATUS, FILTER REMOVAL WAS NOT RECOMMENDED. SHE REPORTED THAT SHE WAS ADVISED THAT NO EXPERIENCE EXISTED TO INDICATE THAT PREGNANCY COULD NOT BE SAFELY ATTEMPTED AS LONG AS ANTICOAGULATION WAS CONTINUED. SEVEN MONTHS LATER, SHE BECAME PREGNANT. AT 24 WEEKS, 2 DAYS GESTATION, IMMEDIATELY FOLLOWING MISSIONARY-POSITION COITUS, SHE EXPERIENCED ACUTE ONSET OF DIFFUSE ABDOMINAL PAIN, BACK PAIN, AND DYSPNEA. ON PHYSICAL EXAMINATION, HER INITIAL BLOOD PRESSURE WAS 115/66 MM HG WITH A HEART RATE OF 152. HER ABDOMEN WAS DIFFUSELY TENDER. GIVEN HER PREVIOUS HISTORY OF PE AND HER COMPLAINTS OF DYSPNEA, PULMONARY COMPUTED TOMOGRAPHIC ANGIOGRAPHY WAS PERFORMED. NO PE WAS FOUND, BUT FREE INTRAPERITONEAL FLUID WAS NOTED. IMMEDIATELY FOLLOWING THE COMPUTED TOMOGRAPHIC ANGIOGRAPHY, HER HEMODYNAMICS DECLINED WITH A CORRESPONDING DECREASE IN FETAL HEART RATE. SHE WAS TAKEN EMERGENTLY TO THE LABOR AND DELIVERY OPERATING ROOM BY THE OBSTETRICAL TEAM FOR CAESAREAN SECTION AND ABDOMINAL EXPLORATION. UPON CELIOTOMY THROUGH A VERTICAL MIDLINE INCISION, AT LEAST 2.5 LITERS OF FREE INTRAPERITONEAL BLOOD WERE ENCOUNTERED. THE FETUS WAS DELIVERED BUT WAS UNABLE TO BE RESUSCITATED AND DIED SHORTLY AFTER BIRTH. UTERINE ATONY WAS ENCOUNTERED AND TREATED WITH INTRAMUSCULAR METHERGINE. A GROUP OF SMALL VERTICAL LACERATIONS, ACTIVELY BLEEDING, WERE NOTED IN THE POSTERIOR WALL OF THE UTERINE DOME, AND THESE WERE REPAIRED WITH ABSORBABLE SUTURE. A TEAR IN THE PERITONEAL MEMBRANE OVERLYING THE FILTER-BEARING IVC WAS PRESENT, WITH FREELY EXPOSED SHARP BARBS AND VERTICAL STRUTS OF THE VCF. THESE STRUTS WERE IN PROXIMITY TO THE UTERINE LACERATIONS. ANTERIORLY, THE EXPOSED STRUTS WERE REMOVED USING WIRE CUTTERS. THE IVC AND RETROPERITONEUM WERE THOROUGHLY INSPECTED. THERE WAS NO RETROPERITONEAL HEMATOMA TO SUGGEST THAT THE INITIAL SOURCE OF BLEEDING HAD ORIGINATED FROM A RETROPERITONEAL STRUCTURE, AND THE IVC WAS FIBROSED IN THE REGION OF THE FILTER. THERE WAS A VERY SMALL AREA OF ADVENTITIAL TRAUMA IN THE REGION OF AN EXTRUDED STRUT, BUT THERE WAS NO EVIDENCE TO INDICATE THIS WAS THE SOURCE OF HER INTRAPERITONEAL HEMORRHAGE. THIS WAS TREATED WITH A SINGLE PROLENE SUTURE. THE REMAINING ELEMENTS OF THE FILTER WERE SECURED WITH TWO ADDITIONAL PROLENE SUTURES TO PREVENT POTENTIAL MIGRATION. GIVEN HER HEMODYNAMIC INSTABILITY AND ANTICOAGULATED STATE, THE LATERAL STRUTS WERE LEFT IN PLACE, AND NO ATTEMPT WAS MADE AT MOBILIZATION OF THE POSTERIOR IVC. A VASCULARIZED, TRANSMESOCOLIC OMENTAL PEDICLE FLAP WAS PLACED AROUND THE FILTER-BEARING REGION OF THE IVC TO SEPARATE SURROUNDING STRUCTURES FROM CONTACT WITH REMAINING ELEMENTS OF THE DEVICE. THE PATIENT¿S TOTAL INPATIENT STAY WAS 13 DAYS AND WAS COMPLICATED BY INTRA-ABDOMINAL ABSCESS TREATED WITH PERCUTANEOUS DRAINAGE AND ANTIBIOTICS, IN ADDITION TO A WOUND INFECTION. SHE HAS BEEN SEEN AT REGULAR FOLLOW-UP INTERVALS (9 MONTHS TO DATE), REMAINED COMPLIANT WITH ANTICOAGULATION THERAPY, AND HAS HAD NO EPISODES OF RECURRENT VENOUS THROMBOEMBOLISM. THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WAS A STERILE LOT NUMBER PROVIDED. WHILE THE REPORTED HEMATOMA, INTRAPERITONEAL HEMORRHAGE, FETAL DEATH, INFECTION, UTERINE ATONY, UTERINE PERFORATION AND ABDOMINAL ABSCESS COULD NOT BE CONFIRMED, IMAGES WITHIN THE ARTICLE NOTE WHAT MAY BE PERFORATION OF THE INFERIOR VENA CAVA. AS SUCH, THE REPORTED ¿INJURY TO THE INFERIOR VENA CAVA¿ IS CONFIRMED. THE EXACT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE IFU NOTES FILTER PERFORATION OF THE VENA CAVA WALL AS A POSSIBLE LONG-TERM COMPLICATION ASSOCIATED WITH FILTER IMPLANTATION. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE PATIENT¿S MEDICAL HISTORY AND CONDITIONS MAY HAVE CONTRIBUTED TO THE EVENTS REPORTED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, AND WITHOUT A LOT NUMBER TO CONDUCT A DHR, THERE IS NO INFORMATION TO SUGGEST THAT DESIGN OR MANUFACTURING PROCESS OF THE DEVICE MAY HAVE CONTRIBUTED TO THIS EVENT; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY MAIJUB ET AL UTERINE TRAUMA WITH FETAL LOSS ASSOCIATED WITH CHRONIC PERFORATION OF THE INFERIOR VENA CAVA BY AN INFRARENAL VENA CAVA FILTER, JOURNAL OF VASCULAR SURGERY 1 (2013) 412-414; AFTER DEPLOYMENT OF A TRAPEASE IVC FILTER, THE PATIENT DEVELOPED A HEMATOMA. FOUR YEARS LATER, DURING A ROUTINE EVALUATION, CT SCAN REVEALED CHRONIC PERFORATION OF THE IVC. THE PATIENT WAS ASYMPTOMATIC AND THE FILTER WAS NOT REMOVED. ABOUT A YEAR LATER, THE PATIENT WAS 24 WEEKS PREGNANT WHEN SHE DEVELOPED ABDOMINAL/BACK PAIN AND DYSPNEA. THE PATIENT HAD INTRAPERITONEAL BLEEDING. AN EMERGENCY C-SECTION WAS PERFORMED AND THE FETUS WAS UNABLE TO BE RESUSCITATED AND DIED. LACERATIONS WERE FOUND ON THE UTERUS AND A TEAR WAS FOUND ON THE PERITONEAL MEMBRANE. UTERINE ATONY DEVELOPED AND WAS TREATED. THE FILTER BARBS WERE CUT AND THE FILTER WAS SUTURED TO PREVENT MIGRATION. THE PATIENT ALSO DEVELOPED AN INTRA-ABDOMINAL ABSCESS AND WOUND INFECTION TREATED WITH DRAINAGE AND ANTIBIOTICS. A WOMAN, WHO WAS THEN 27 YEARS OLD, WITH A KNOWN HISTORY OF DEEP VENOUS THROMBOSIS, RECURRENT PULMONARY EMBOLI (PE), AND WARFARIN ALLERGY, WAS EVALUATED FOR IVC INTERRUPTION WITH A VCF DUE TO RETROPERITONEAL HEMORRHAGE COMPLICATING ANTICOAGULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415658 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DTK CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| L| R| S