BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 3013949 · Received March 20, 2013

    Report

    Report Number
    9616099-2013-00162
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    June 30, 2015
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED AT A MEDICAL CONFERENCE FROM A (B)(6). ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    MODIFICATIONS MADE TO THE PREVIOUSLY REPORTED EVENT NOTED BELOW. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO FURTHER REPORTS WILL BE FORTHCOMING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PUBLICATION OF THE FULL ARTICLE. THERE WERE TWO ATTEMPTS AT ENDOVENOUS REMOVAL AND NO EVIDENCE OF FRACTURE. THE INDICATION FOR REMOVAL WAS DUE TO ABDOMINAL PAIN, ENTERIC HEMORRHAGE, IVC PERFORATION AND DUODENAL PERFORATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PUBLICATION OF THE FULL ARTICLE. THERE WERE TWO ATTEMPTS AT ENDOVENOUS REMOVAL AND NO EVIDENCE OF FRACTURE. THE INDICATION FOR REMOVAL WAS DUE TO ABDOMINAL PAIN, ENTERIC HEMORRHAGE, IVC PERFORATION AND DUODENAL PERFORATION. THE DURATION OF THE IMPLANT WAS 9 MONTHS AND THERE WERE 0 ATTEMPTS AT REMOVAL. TWO PATIENTS HAD PERMANENT BARD TRAPEASE IVC FILTERS (CORDIS CORPORATION, HIALEAH, FLA) IMPLANTED 6 AND 9 MONTHS PREVIOUSLY. L PATIENTS HAD PREOPERATIVE IMAGING DEMONSTRATING IVC PERFORATION. FOUR PATIENTS (THREE WITH OPTIONAL FILTERS AND ONE WITH A PERMANENT FILTER) HAD ATTEMPTS AT ENDOVENOUS REMOVAL; ONE PATIENT HAD TWO AND ANOTHER HAD THREE ATTEMPTS. ADVANCED ENDOVENOUS MANEUVERS TO REMOVE FILTERS INCLUDED THE USE OF JUGULAR-FEMORAL THROUGH-AND-THROUGH ACCESS, WIRE LOOPS, AND BIOPSY FORCEPS. . MEAN HOSPITAL STAY WAS 3.6 DAYS (RANGE, 1-5 DAYS). THERE WAS NO MORTALITY, NO MAJOR OR MINOR COMPLICATIONS, AND NO DEEP VENOUS THROMBOSIS OR PULMONARY EMBOLISM (PE). ALL PATIENTS WERE DISCHARGED HOME WITHOUT COMPLICATIONS. POSTOPERATIVELY, ORAL ANTICOAGULATION WAS MAINTAINED FOR THE THREE PATIENTS WHO ALSO RECEIVED HEPARIN INTRAOPERATIVELY. TWO OF THESE HAD CAVOTOMY, EXCISION OF A PERMANENT TRAPEASE FILTER, AND REPAIR OF INTIMAL DEFECTS. NO PATIENT IS CURRENTLY ANTICOAGULATED. NO EARLY OR DELAYED COMPLICATIONS, DEEP VENOUS THROMBOSIS, OR CLINICALLY SIGNIFICANT PE WAS ENCOUNTERED AT A MEAN FOLLOW-UP OF 1.3 YEARS, RANGING FROM 1 MONTH TO 2.8 YEARS. RANA ET AL SURGICAL REMOVAL OF RETAINED AND DISLODGED INFERIOR VENA CAVA FILTERS; AMERICAN VENOUS FORUM 25TH SILVER ANNIVERSARY MEETING 2013; REPORT THAT 6 MONTHS AFTER IMPLANTATION OF A CORDIS TRAPEASE PLACED FOR UNPROVOKED DVT AND PE, TWO ATTEMPTS WERE MADE FOR REMOVAL DUE TO IVC PERFORATION (NOTED DURING PREOPERATIVE IMAGING), DUODENAL PERFORATION AND INTESTINAL HEMORRHAGE. THERE WAS ALSO PROXIMAL DISLODGEMENT. ADVANCED ENDOVENOUS MANEUVERS TO REMOVE THE FILTER WERE USED; HOWEVER, CAVOTOMY EXCISION OF THE TRAPEASE FILTER AND REPAIR OF INTIMAL DEFECTS WAS CONDUCTED. THERE WERE NO MAJOR OR MINOR COMPLICATIONS, NO DEEP VEIN THROMBOSIS OR PE. THE PATIENT WAS DISCHARGED HOME WITHIN 5 DAYS WITHOUT COMPLICATIONS. THE PATIENT IS CURRENTLY NOT ON ANTICOAGULATION. NO EARLY OR DELAY COMPLICATIONS, DVT, OR CLINICALLY SIGNIFICANT PE WAS ENCOUNTERED AT FOLLOW UP. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. POSSIBLE PROCEDURE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: AIR EMBOLISM, HEMATOMA AT THE PUNCTURE SITE, INCORRECT POSITIONING OF THE FILTER, PERFORATION OF THE VESSEL WALL, RESTRICTION OF BLOOD FLOW, OCCLUSION OF SMALL VESSEL, DISTAL EMBOLIZATION, INFECTION, INTIMAL TEAR, FILTER FRACTURE, THROMBUS FORMATION. POSSIBLE LONGER-TERM COMPLICATIONS ASSOCIATED WITH FILTER IMPLANTATION INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER OBSTRUCTION, FILTER PERFORATION OF THE VENA CAVA WALL, FILTER MIGRATION, FILTER FRACTURE, RECURRENT PULMONARY EMBOLISM. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENTS. 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 ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE FULL PUBLICATION OF THIS EVENT PREVIOUSLY REPORTED BECAME AVAILABLE AND THE DETAILS ARE UPDATED ACCORDINGLY. THE FULL ARTICLE IS ALSO ATTACHED. (B)(6) ET AL SURGICAL REMOVAL OF RETAINED AND DISLODGED INFERIOR VENA CAVA FILTERS; (B)(6) 2013; REPORT THAT 6 MONTHS AFTER IMPLANTATION OF A CORDIS TRAPEASE IN A (B)(6) MALE PATIENT, TWO ATTEMPTS WERE MADE FOR REMOVAL DUE TO IVC PERFORATION, DUODENAL PERFORATION AND INTESTINAL HEMORRHAGE. THERE WAS ALSO PROXIMAL DISLODGEMENT. THE INDICATION FOR PLACEMENT INCLUDED UNPROVOKED DEEP VENOUS THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). ADDITIONAL INFORMATION WAS RECEIVED FROM THE PUBLICATION OF THE FULL ARTICLE. THERE WERE TWO ATTEMPTS AT ENDOVENOUS REMOVAL AND NO EVIDENCE OF FRACTURE. THE INDICATION FOR REMOVAL WAS DUE TO ABDOMINAL PAIN, ENTERIC HEMORRHAGE, IVC PERFORATION AND DUODENAL PERFORATION. INDICATIONS, PROCEDURAL DETAILS, AND OUTCOME IN ALL PATIENTS WHO UNDERWENT OPEN SURGICAL REMOVAL OF COMPLICATED AND DISLODGED (FIG 1) IVC FILTERS WERE RETROSPECTIVELY REVIEWED. SIX PATIENTS (FOUR MEN, TWO WOMEN) WITH A MEAN AGE OF (B)(6) (RANGE, 30-73) YEARS UNDERWENT OPEN SURGICAL REMOVAL OF IVC FILTERS. TWO PATIENTS HAD PERMANENT BARD TRAPEASE IVC FILTERS ((B)(4)) IMPLANTED 6 AND 9 MONTHS PREVIOUSLY. FOUR PATIENTS HAD OPTIONAL FILTERS PLACED. TWO PATIENTS HAD COOK CELECT ((B)(4)), AND TWO HAD BARD FILTERS (BARD G2, N ¼ 1; BARD ECLIPSE, N ¼ 1; (B)(4)). THE OPTIONAL FILTERS WERE IMPLANTED AT 7, 23, 33, AND 35 MONTHS BEFORE REMOVAL. ALL OPERATIONS WERE PERFORMED UNDER GENERAL ANESTHESIA, THROUGH RIGHT SUBCOSTAL (N ¼ 4) OR MIDLINE LAPAROTOMIES (N ¼ 2). THE POSTERIOR PERITONEUM WAS INCISED LATERAL TO THE ASCENDING COLON, THE RETROPERITONEUM WAS ENTERED, THE DUODENUM WAS MOBILIZED AND RETRACTED TO THE LEFT, AND THE IVC WAS EXPOSED. FURTHER TECHNIQUES IN PATIENTS WITH PERMANENT FILTERS DIFFERED FROM THOSE IN PATIENTS WITH OPTIONAL FILTERS AND IN THE PATIENT WITH THE BROKEN STRUT LODGED IN THE VERTEBRAL BODY. LUMBAR BRANCHES OF THE IVC AND THE RENAL VEINS ARE ENCIRCLED AND OCCLUDED WITH VESSEL LOOPS, THE PATIENT IS HEPARINIZED, AND THE IVC IS CLAMPED PROXIMAL AND DISTAL TO THE FILTER. (BOTH PATIENTS IN THIS SERIES HAD PERMANENT TRAPEASE FILTERS.) A LONGITUDINAL CAVOTOMY IS MADE AND THE FILTER EXTRACTED. THE LIMBS OF THE FILTER ARE USUALLY COVERED BY INTIMAL HYPERPLASIA, AND EXCISION RESULTS IN MULTIPLE DEFECTS IN THE INTIMA. THESE ARE CLOSED WITH INTERRUPTED AND RUNNING 6-0 POLYPROPYLENE SUTURES, AND THE CAVA IS CLOSED WITH DIRECT CLOSURE. THE FILTER STRUTS PROTRUDING THROUGH THE IVC INTO AORTA, SPINE, AND VISCERA ARE USUALLY CUT OUTSIDE THE IVC WITH A WIRE CUTTER, AND THEIR DISTAL END IS REMOVED FROM THE ORGANS SEPARATELY. IF THEY ARE NOT IN THE VISUAL FIELD AND DISSECTION IS DIFFICULT, THEY ARE REMOVED WITH THE FILTER THROUGH THE IVC. IN ONE OF OUR PATIENTS WHO PRESENTED WITH MELENA, THE STRUT WAS REMOVED FROM THE DUODENUM WALL AND THE BOWEL REPAIRED PRIMARILY WITH SEROMUSCULAR SUTURES. UNFRACTIONATED HEPARIN WAS GIVEN INTRAOPERATIVELY TO THREE PATIENTS TO KEEP THE ACTIVATED CLOTTING TIME >220 SECONDS. TWO OF THESE PATIENTS REQUIRED IVC CLAMPING, AND THE THIRD PATIENT HAD PARTIAL THROMBOSIS OF THE IVC WHEN THE FILTER WAS REMOVED THROUGH A SMALL STAB WOUND MADE IN THE VENA CAVA. THE REMAINING PATIENTS, WHO HAD NO CAVAL CLAMPING AND HAD NO THROMBUS IN THE FILTER, WERE NOT ANTICOAGULATED DURING THE PROCEDURE. MEAN HOSPITAL STAY WAS 3.6 DAYS (RANGE, 1-5 DAYS). THERE WAS NO MORTALITY, NO MAJOR OR MINOR COMPLICATIONS, AND NO DEEP VENOUS THROMBOSIS OR PULMONARY EMBOLISM (PE). ALL PATIENTS WERE DISCHARGED HOME WITHOUT COMPLICATIONS. POSTOPERATIVELY, ORAL ANTICOAGULATION WAS MAINTAINED FOR THE THREE PATIENTS WHO ALSO RECEIVED HEPARIN INTRAOPERATIVELY. TWO OF THESE HAD CAVOTOMY, EXCISION OF A PERMANENT TRAPEASE FILTER, AND REPAIR OF INTIMAL DEFECTS. THE THIRD PATIENT HAD THROMBUS IN THE IVC. THE PERIOD OF ANTICOAGULATION WAS 6 MONTHS IN TWO PATIENTS AND 12 MONTHS IN THE THIRD. NO PATIENT IS CURRENTLY ANTICOAGULATED. NO EARLY OR DELAYED COMPLICATIONS, DEEP VENOUS THROMBOSIS, OR CLINICALLY SIGNIFICANT PE WAS ENCOUNTERED AT A MEAN FOLLOW-UP OF 1.3 YEARS, RANGING FROM 1 MONTH TO 2.8 YEARS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. POSSIBLE PROCEDURE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: AIR EMBOLISM, HEMATOMA AT THE PUNCTURE SITE, INCORRECT POSITIONING OF THE FILTER, PERFORATION OF THE VESSEL WALL, RESTRICTION OF BLOOD FLOW, OCCLUSION OF SMALL VESSEL, DISTAL EMBOLIZATION, INFECTION, INTIMAL TEAR, FILTER FRACTURE, THROMBUS FORMATION. POSSIBLE LONGER-TERM COMPLICATIONS ASSOCIATED WITH FILTER IMPLANTATION INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER OBSTRUCTION, FILTER PERFORATION OF THE VENA CAVA WALL, FILTER MIGRATION, FILTER FRACTURE, RECURRENT PULMONARY EMBOLISM. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENTS. 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 ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    KANA ET AL SURGICAL REMOVAL OF RETAINED AND DISLODGED INFERIOR VENA CAVA FILTERS; (B)(6); REPORT THAT 6 MONTHS AFTER IMPLANTATION OF A CORDIS TRAPEASE IN A (B)(6) MALE PATIENT, TWO ATTEMPTS WERE MADE FOR REMOVAL DUE TO IVC PERFORATION, DUODENAL PERFORATION AND INTESTINAL HEMORRHAGE. THERE WAS ALSO PROXIMAL DISLODGEMENT. THE INDICATION FOR PLACEMENT INCLUDED UNPROVOKED DEEP VENOUS THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). PROCEDURAL AND PATIENT DETAILS WERE NOT PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. POSSIBLE PROCEDURE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: AIR EMBOLISM, HEMATOMA AT THE PUNCTURE SITE, INCORRECT POSITIONING OF THE FILTER, PERFORATION OF THE VESSEL WALL, RESTRICTION OF BLOOD FLOW, OCCLUSION OF SMALL VESSEL, DISTAL EMBOLIZATION, INFECTION, INTIMAL TEAR, FILTER FRACTURE, THROMBUS FORMATION. POSSIBLE LONGER-TERM COMPLICATIONS ASSOCIATED WITH FILTER IMPLANTATION INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER OBSTRUCTION, FILTER PERFORATION OF THE VENA CAVA WALL, FILTER MIGRATION, FILTER FRACTURE, RECURRENT PULMONARY EMBOLISM. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENTS. 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 ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    (B)(6) REPORT THAT 6 MONTHS AFTER IMPLANTATION OF A CORDIS TRAPEASE IN A (B)(6) MALE PATIENT, TWO ATTEMPTS WERE MADE FOR REMOVAL DUE TO IVC PERFORATION, DUODENAL PERFORATION AND INTESTINAL HEMORRHAGE. THERE WAS ALSO PROXIMAL DISLODGEMENT. THE INDICATION FOR PLACEMENT INCLUDED UNPROVOKED DEEP VENOUS THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116480 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR