TRAPEASE FILTER
Report
- Report Number
- 9616099-2013-00398
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- March 14, 2003
- Report Date
- June 9, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DTK
- PMA / PMN Number
- K020316
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
JOSHI ET AL, THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA TREATED WITH A GIANTURCO STENT, J VASC INTERV RADIOL 2003; 14:381¿385; REPORT A CASE OF COMPLETE THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA (IVC), WHICH OCCURRED 4 WEEKS AFTER PLACEMENT OF AN IVC FILTER (TRAPEASE; CORDIS, MIAMI FL). INITIAL TREATMENT WITH SUCTION THROMBECTOMY AND THROMBOLYSIS WAS INEFFECTIVE. PERCUTANEOUS REMOVAL OF THE FILTER WAS UNSUCCESSFUL BECAUSE OF THE LONG PERIOD OF IMPLANTATION. AN EXPANDABLE METALLIC GIANTURCO Z STENT WAS USED TO EXCLUDE THE FILTER FROM THE VESSEL LUMEN. A (B)(6) MAN WITH NO SIGNIFICANT MEDICAL HISTORY WAS ADMITTED FOR PERCUTANEOUS THROMBECTOMY OF AN ACUTE THROMBOTIC OCCLUSION OF THE IVC. THE PATIENT HAD SUSTAINED MULTIPLE INJURIES, INCLUDING A RIGHT RENAL HEMATOMA, AFTER A FALL FROM A LADDER 6 WEEKS PREVIOUSLY. HE RECOVERED RAPIDLY AND WAS DISCHARGED IN 3 DAYS. TWO WEEKS LATER, AFTER A 12-HOUR ROAD TRIP, HE PRESENTED TO THE HOSPITAL WITH SEVERE BACK AND LEFT-SIDED PLEURITIC CHEST PAIN. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OF THE THORAX REVEALED SMALL SEGMENTAL PULMONARY EMBOLI IN THE LEFT LOWER LOBE. BECAUSE OF THE RECENT HISTORY OF TRAUMATIC RIGHT RENAL HEMATOMA AND BLEEDING RISKS ASSOCIATED WITH ANTICOAGULATION, A TRAPEASE FILTER WAS PLACED IN THE INFRARENAL IVC. APPROXIMATELY 4 WEEKS AFTER INSERTION OF THE IVC FILTER, THE PATIENT DEVELOPED PROGRESSIVE BILATERAL LOWER EXTREMITY SWELLING AND SCROTAL EDEMA. CONTRAST-ENHANCED CT OF THE ABDOMEN AND PELVIS REVEALED OCCLUSIVE THROMBUS IN THE IVC THAT EXTENDED FROM BELOW THE FILTER INTO THE COMMON AND EXTERNAL ILIAC VEINS BILATERALLY. THE PATIENT WAS TRANSFERRED FOR MANAGEMENT OF COMPLETE IVC THROMBOSIS. THE PATIENT WAS PLACED IN A PRONE POSITION ON THE PROCEDURE TABLE AND BOTH POPLITEAL VEINS WERE ACCESSED. VASCULAR SHEATHS WERE INSERTED BILATERALLY AND INITIAL BILATERAL LOWER-EXTREMITY VENOGRAPHY REVEALED OCCLUSIVE THROMBUS IN THE COMMON FEMORAL, EXTERNAL, AND COMMON ILIAC VEINS AND LOWER IVC. BOTH SUPERFICIAL FEMORAL VEINS WERE PATENT. IVC VENOGRAPHY PERFORMED WITH A 5-F PIGTAIL CATHETER PLACED ABOVE THE FILTER REVEALED THAT THE IVC ABOVE THE FILTER WAS PATENT AND FREE OF THROMBUS. MECHANICAL THROMBECTOMY WAS ATTEMPTED BILATERALLY WITH A THROMBECTOMY CATHETER INSERTED SEPARATELY VIA BOTH LEFT AND RIGHT SHEATHS. AFTER SEVERAL PASSES OF THE CATHETER, ONLY MODERATE DEBULKING WAS ACHIEVED IN BOTH COMMON FEMORAL VEINS WITH PERSISTENCE OF BULKY ILIO-CAVAL THROMBUS. THROMBOLYTIC THERAPY WAS INITIATED WITH 5-F, 30-CM-LONG MULTIPLE-SIDE HOLE INFUSION CATHETERS. THE CATHETER WAS POSITIONED SO THAT THE INFUSION LENGTH EXTENDED THROUGH THE ENTIRE LENGTH OF THROMBUS FROM THE COMMON FEMORAL VEINS TO A LEVEL JUST ABOVE THE FILTER IN THE IVC. THROMBOLYTICS WAS INFUSED VIA EACH OF THE CATHETERS. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT FOR POSSIBLE COMPLICATIONS OF THROMBOLYTIC THERAPY. FOLLOW-UP VENOGRAPHY WAS PERFORMED MULTIPLE TIMES AFTER INITIATION OF THROMBOLYTIC THERAPY AND REVEALED PROGRESSIVE REDUCTION OF CLOT BURDEN, WITH CLEARING OF THROMBUS IN THE COMMON FEMORAL VEINS BUT PERSISTENT NONOCCLUSIVE THROMBUS IN THE EXTERNAL AND COMMON ILIAC VEINS BILATERALLY. PERSISTENT FLOW-LIMITING THROMBUS WAS ALSO PRESENT IN THE FILTER AND LOWER IVC. SMART STENTS (14 X 80 MM) WERE INSERTED INTO THE COMMON ILIAC VEINS BILATERALLY TO TREAT NON-OCCLUSIVE THROMBOSIS. REPEAT THROMBECTOMY RESULTED IN NO SIGNIFICANT IMPROVEMENT. BECAUSE OF PERSISTENT OCCLUSIVE THROMBUS IN THE IVC FILTER, AN ATTEMPT WAS MADE TO REMOVE THE FILTER. THE RIGHT INTERNAL JUGULAR AND RIGHT COMMON FEMORAL VEINS WERE ACCESSED AND VASCULAR SHEATHS WERE PLACED. J-TIPPED GUIDE WIRES WERE INSERTED THROUGH THE UPPER AND LOWER INTERSTICES OF THE FILTER AND THE DISTAL ENDS OF THE WIRES WERE SNARED FROM ABOVE AND BELOW WITH AMPLATZ GOOSENECK SNARES. ALTHOUGH BOTH WIRES WERE PULLED ON FROM ABOVE AND BELOW, IT WAS NOT POSSIBLE TO REMOVE THE FILTER BECAUSE IT WAS STRONGLY ADHERED TO THE VENA CAVAL WALL. A DECISION WAS THEN MADE TO EXCLUDE THE FILTER FROM THE IVC LUMEN WITH USE OF AN EXPANDABLE METALLIC STENT (COOK). THE RIGHT GROIN VASCULAR SHEATH WAS EXCHANGED FOR THE 16-F VASCULAR SHEATH. A 25-MM-DIAMETER Z STENT (COOK) WAS INSERTED AND DEPLOYED ACROSS THE IVC FILTER. COMPLETION VENOGRAPHY REVEALED SATISFACTORY FLATTENING OF THE FILTER AGAINST THE VENA CAVAL WALL WITH COMPLETE PATENCY OF THE LOWER IVC. NON-OCCLUSIVE THROMBUS IN THE PELVIC VEINS WAS THEN TREATED BY PLACEMENT OF SELF-EXPANDING METAL STENTS IN THE EXTERNAL ILIAC VEINS. SMART STENTS (14 X 80 MM) WERE INSERTED VIA THE RIGHT GROIN AND RIGHT INTERNAL JUGULAR VEIN SHEATHS AND DEPLOYED IN THE COMMON AND EXTERNAL ILIAC VEINS BILATERALLY. FOLLOW-UP VENOGRAPHY REVEALED PATENCY OF THE INFERIOR VENA CAVA, ILIAC, AND COMMON FEMORAL VEINS BILATERALLY WITH NO EVIDENCE OF RESIDUAL THROMBUS. THE PATIENT HAD COMPLETE RESOLUTION OF SYMPTOMS AND WAS DISCHARGED THE FOLLOWING DAY WITH A PRESCRIPTION FOR THE ORAL ANTICOAGULANT COUMADIN. POST PROCEDURE DUPLEX ULTRASONOGRAPHY OF THE IVC WAS UNREMARKABLE AND THE PATIENT REMAINS SYMPTOM-FREE AT 6-MONTH FOLLOW-UP. IN CONCLUSION, THROMBOTIC OCCLUSION OF THE IVC IS A RARE BUT POTENTIALLY LETHAL COMPLICATION OF IVC FILTERS. THROMBUS EMBEDDED IN THE FILTER MAY BE DIFFICULT TO CLEAR AND MAY PRODUCE A PERSISTENT FLOW-LIMITING OCCLUSION. IN CASES WHERE THE FILTER CANNOT BE REMOVED, IT IS POSSIBLE TO COLLAPSE IT AGAINST THE VENA CAVAL WALL WITH USE OF A GIANTURCO EXPANDABLE METALLIC STENT (COOK), THEREBY REESTABLISHING THE PATENCY OF THE IVC. THE PRODUCT REMAINED IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE IFU LISTS FILTER OBSTRUCTION AS A POSSIBLE PROCEDURE COMPLICATION POST IMPLANTATION. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THROMBUS IN THE FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. PATIENT AND PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS THE THROMBUS FORMATION LEADING TO THE FILTER OCCLUSION. THE INFORMATION PROVIDED DOES NOT SUGGEST THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
THE PATIENT WAS PLACED IN A PRONE POSITION ON THE PROCEDURE TABLE AND BOTH POPLITEAL VEINS WERE ACCESSED. VASCULAR SHEATHS WERE INSERTED BILATERALLY AND INITIAL BILATERAL LOWER-EXTREMITY VENOGRAPHY REVEALED OCCLUSIVE THROMBUS IN THE COMMON FEMORAL, EXTERNAL, AND COMMON ILIAC VEINS AND LOWER IVC. BOTH SUPERFICIAL FEMORAL VEINS WERE PATENT. IVC VENOGRAPHY PERFORMED WITH A 5-F PIGTAIL CATHETER PLACED ABOVE THE FILTER REVEALED THAT THE IVC ABOVE THE FILTER WAS PATENT AND FREE OF THROMBUS. MECHANICAL THROMBECTOMY WAS ATTEMPTED BILATERALLY WITH A THROMBECTOMY CATHETER INSERTED SEPARATELY VIA BOTH LEFT AND RIGHT SHEATHS. AFTER SEVERAL PASSES OF THE CATHETER, ONLY MODERATE DEBULKING WAS ACHIEVED IN BOTH COMMON FEMORAL VEINS WITH PERSISTENCE OF BULKY ILIO-CAVAL THROMBUS. THROMBOLYTIC THERAPY WAS INITIATED WITH 5-F, 30-CM-LONG MULTIPLE-SIDE HOLE INFUSION CATHETERS. THE CATHETER WAS POSITIONED SO THAT THE INFUSION LENGTH EXTENDED THROUGH THE ENTIRE LENGTH OF THROMBUS FROM THE COMMON FEMORAL VEINS TO A LEVEL JUST ABOVE THE FILTER IN THE IVC. THROMBOLYTICS WAS INFUSED VIA EACH OF THE CATHETERS. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT FOR POSSIBLE COMPLICATIONS OF THROMBOLYTIC THERAPY. FOLLOW-UP VENOGRAPHY WAS PERFORMED MULTIPLE TIMES AFTER INITIATION OF THROMBOLYTIC THERAPY AND REVEALED PROGRESSIVE REDUCTION OF CLOT BURDEN, WITH CLEARING OF THROMBUS IN THE COMMON FEMORAL VEINS BUT PERSISTENT NONOCCLUSIVE THROMBUS IN THE EXTERNAL AND COMMON ILIAC VEINS BILATERALLY. PERSISTENT FLOW-LIMITING THROMBUS WAS ALSO PRESENT IN THE FILTER AND LOWER IVC. SMART STENTS (14 X 80 MM) WERE INSERTED INTO THE COMMON ILIAC VEINS BILATERALLY TO TREAT NON-OCCLUSIVE THROMBOSIS. REPEAT THROMBECTOMY RESULTED IN NO SIGNIFICANT IMPROVEMENT. BECAUSE OF PERSISTENT OCCLUSIVE THROMBUS IN THE IVC FILTER, AN ATTEMPT WAS MADE TO REMOVE THE FILTER. THE RIGHT INTERNAL JUGULAR AND RIGHT COMMON FEMORAL VEINS WERE ACCESSED AND VASCULAR SHEATHS WERE PLACED. J-TIPPED GUIDE WIRES WERE INSERTED THROUGH THE UPPER AND LOWER INTERSTICES OF THE FILTER AND THE DISTAL ENDS OF THE WIRES WERE SNARED FROM ABOVE AND BELOW WITH AMPLATZ GOOSENECK SNARES. ALTHOUGH BOTH WIRES WERE PULLED ON FROM ABOVE AND BELOW, IT WAS NOT POSSIBLE TO REMOVE THE FILTER BECAUSE IT WAS STRONGLY ADHERED TO THE VENA CAVAL WALL. A DECISION WAS THEN MADE TO EXCLUDE THE FILTER FROM THE IVC LUMEN WITH USE OF AN EXPANDABLE METALLIC STENT (COOK). THE RIGHT GROIN VASCULAR SHEATH WAS EXCHANGED FOR THE 16-F VASCULAR SHEATH. A 25-MM-DIAMETER Z STENT (COOK) WAS INSERTED AND DEPLOYED ACROSS THE IVC FILTER. COMPLETION VENOGRAPHY REVEALED SATISFACTORY FLATTENING OF THE FILTER AGAINST THE VENA CAVAL WALL WITH COMPLETE PATENCY OF THE LOWER IVC. NON-OCCLUSIVE THROMBUS IN THE PELVIC VEINS WAS THEN TREATED BY PLACEMENT OF SELF-EXPANDING METAL STENTS IN THE EXTERNAL ILIAC VEINS. SMART STENTS (14 X 80 MM) WERE INSERTED VIA THE RIGHT GROIN AND RIGHT INTERNAL JUGULAR VEIN SHEATHS AND DEPLOYED IN THE COMMON AND EXTERNAL ILIAC VEINS BILATERALLY. FOLLOW-UP VENOGRAPHY REVEALED PATENCY OF THE INFERIOR VENA CAVA, ILIAC, AND COMMON FEMORAL VEINS BILATERALLY WITH NO EVIDENCE OF RESIDUAL THROMBUS. THE PATIENT HAD COMPLETE RESOLUTION OF SYMPTOMS AND WAS DISCHARGED THE FOLLOWING DAY WITH A PRESCRIPTION FOR THE ORAL ANTICOAGULANT COUMADIN. POST PROCEDURE DUPLEX ULTRASONOGRAPHY OF THE IVC WAS UNREMARKABLE AND THE PATIENT REMAINS SYMPTOM-FREE AT 6-MONTH FOLLOW-UP. CONCOMITANT DEVICES: VASCULAR SHEATHS (7-F; COOK), 6-F POSSIS ANGIOJET XPEEDIOR CATHETER , 5-F, 30-CM-LONG MULTIPLE-SIDE HOLE INFUSION CATHETERS, SMART STENTS (14 - 80 MM), GIANTURCO METALLIC STENT (COOK), AMPLATZ GOOSENECK SNARES THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
JOSHI ET AL FILTER-RELATED, THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA TREATED WITH A GIANTURCO STENT, J VASC INTERV RADIOL 2003; 14:381¿385; REPORT CASE OF COMPLETE THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA (IVC), WHICH OCCURRED 4 WEEKS AFTER PLACEMENT OF AN IVC FILTER (TRAPEASE; CORDIS, (B)(4)). INITIAL TREATMENT WITH SUCTION THROMBECTOMY AND THROMBOLYSIS WAS INEFFECTIVE. PERCUTANEOUS REMOVAL OF THE FILTER WAS UNSUCCESSFUL BECAUSE OF THE LONG PERIOD OF IMPLANTATION. AN EXPANDABLE METALLIC GIANTURCO Z STENT WAS USED TO EXCLUDE THE FILTER FROM THE VESSEL LUMEN. A (B)(6) MAN WITH NO SIGNIFICANT MEDICAL HISTORY WAS ADMITTED FOR PERCUTANEOUS THROMBECTOMY OF AN ACUTE THROMBOTIC OCCLUSION OF THE IVC. THE PATIENT HAD SUSTAINED MULTIPLE INJURIES, INCLUDING A RIGHT RENAL HEMATOMA, AFTER A FALL FROM A LADDER 6 WEEKS PREVIOUSLY. HE RECOVERED RAPIDLY AND WAS DISCHARGED IN 3 DAYS. TWO WEEKS LATER, AFTER A 12-HOUR ROAD TRIP, HE PRESENTED TO THE HOSPITAL WITH SEVERE BACK AND LEFT-SIDED PLEURITIC CHEST PAIN. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OF THE THORAX REVEALED SMALL SEGMENTAL PULMONARY EMBOLI IN THE LEFT LOWER LOBE. BECAUSE OF THE RECENT HISTORY OF TRAUMATIC RIGHT RENAL HEMATOMA AND BLEEDING RISKS ASSOCIATED WITH ANTICOAGULATION, A TRAPEASE FILTER WAS PLACED IN THE INFRARENAL IVC. APPROXIMATELY 4 WEEKS AFTER INSERTION OF THE IVC FILTER, THE PATIENT DEVELOPED PROGRESSIVE BILATERAL LOWER EXTREMITY SWELLING AND SCROTAL EDEMA. CONTRAST-ENHANCED CT OF THE ABDOMEN AND PELVIS REVEALED OCCLUSIVE THROMBUS IN THE IVC THAT EXTENDED FROM BELOW THE FILTER INTO THE COMMON AND EXTERNAL ILIAC VEINS BILATERALLY. THE PATIENT WAS TRANSFERRED FOR MANAGEMENT OF COMPLETE IVC THROMBOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292760 | TRAPEASE FILTER | THROMBECTOMY SYSTEMS (DQO) | DTK | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| L| R |