UNKNOWN OPTEASE VENA CAVA FILTER
Report
- Report Number
- 9616099-2012-00679
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- January 1, 2004
- Report Date
- November 8, 2012
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DTK
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THIS LITERATURE ARTICLE KARMY-JONES ET AL PRACTICE PATTERNS AND OUTCOMES OF RETRIEVABLE VENA CAVA FILTERS IN TRAUMA PATIENTS: AN AAST MULTICENTER STUDY; THE JOURNAL OF TRAUMA_ INJURY, INFECTION, AND CRITICAL CARE 2007; 62:17-25; THE PURPOSE OF THIS STUDY IS TO DESCRIBE PRACTICE PATTERNS AND OUTCOMES OF POSTTRAUMATIC RETRIEVABLE INFERIOR VENA CAVAL FILTERS (R-IVCF). A RETROSPECTIVE REVIEW OF R-IVCFS PLACED DURING 2004 AT 21 PARTICIPATING CENTERS WITH FOLLOW UP TO JULY 1, 2005 WAS PERFORMED. PRIMARY OUTCOMES INCLUDED MAJOR COMPLICATIONS (MIGRATION, PULMONARY EMBOLISM [PE], AND SYMPTOMATIC CAVAL OCCLUSION) AND REASONS FOR FAILURE TO RETRIEVE. THE ARTICLE REPORTS THAT OF THE PATIENTS TREATED WITH THE OPTEASE VENA CAVA FILTER, THERE WERE ELEVEN ATTEMPTS MADE TO RETRIEVE THE FILTER, THREE WERE TECHNICALLY UNABLE TO BE REMOVED, FIVE HAD RESIDUAL THROMBUS AND FOUR HAD SYMPTOMATIC CAVAL OCCLUSION. THE MAJORITY WERE PLACED IN THE ANGIOGRAPHY SUITE BY INTERVENTIONAL RADIOLOGISTS. PLACEMENT OCCURRED 6 TO 8 DAYS AFTER ADMISSION AND RETRIEVAL WAS ATTEMPTED AT 50 TO 61 DAYS IN 116 (28%) CASES. THIS WAS NOT TECHNICALLY POSSIBLE IN 25 (22%) CASES EITHER BECAUSE OF TECHNICAL INABILITY OR DOCUMENTATION OF RESIDUAL THROMBUS IN THE IVC OR TRAPPED IN THE FILTERS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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. THE IFU STATES THAT RETRIEVAL OF THE OPTEASE FILTER SHOULD NOT BE ATTEMPTED IF THROMBUS IS PRESENT IN THE FILTER AND/OR CAUDAL TO THE FILTER. THROMBOSIS IN THE FILTER IS A WELL KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENTS'. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. IT IS RECOGNIZED THAT THROMBI USUALLY DEVELOP FIRST IN THE CALF VEINS, "GROWING" IN THE DIRECTION OF FLOW OF THE VEIN. DVTS ARE DISTINGUISHED AS BEING ABOVE OR BELOW THE POPLITEAL VEIN. VERY EXTENSIVE DVTS CAN EXTEND INTO THE ILIAC VEINS OR THE INFERIOR VENA CAVA EFFECTIVELY BLOCKING BLOOD FLOW. DVT OCCURS WHEN A BLOOD CLOT FORMS IN A DEEP VEIN AND IS MOST COMMON IN THE DEEP VEINS OF YOUR LOWER LEG (CALF), AND CAN SPREAD UP TO THE VEINS IN YOUR THIGH. DVT CAN ALSO FIRST DEVELOP IN THE DEEP VEINS IN YOUR THIGH AND, MORE RARELY, IN OTHER DEEP VEINS, SUCH AS THE ONES IN YOUR ARM. DEEP VEIN THROMBOSIS IS THE RESULT OF THREE PRINCIPAL FACTORS : REDUCED OR STAGNANT BLOOD FLOW IN DEEP VEINS (VENOUS STASIS). INJURY TO THE BLOOD VESSEL WALL. AN INCREASE IN THE ACTIVITY OF THOSE SUBSTANCES IN THE BLOOD THAT ARE PART OF THE NORMAL CLOTTING MECHANISM, A CONDITION CALLED HYPERCOAGULABILITY (WHICH MEANS A MORE ACTIVE CLOTTING STATE). PLACEMENT OF A VENA CAVA FILTER IS NOT A CURE FOR DVT NOR DOES IT PREVENT THE FORMATION OF DVT. INFERIOR VENA CAVA FILTERS ARE USED TO PREVENT SEQUELAE, ESPECIALLY PE, IN PATIENTS WITH CONTRAINDICATIONS TO, COMPLICATIONS OF, OR FAILURE OF ANTICOAGULATION THERAPY AND PATIENTS WITH EXTENSIVE FREE-FLOATING THROMBI OR RESIDUAL THROMBI FOLLOWING MASSIVE PE. PLACEMENT OF A VENA CAVA FILTER REDUCES, BUT DOES NOT ELIMINATE THE RISK OF SYMPTOMATIC PE IN PATIENTS WITH PROXIMAL DVT IN THE SHORT-TERM AND DOES NOT PREVENT SMALL PE. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. THERE IS NO MEDICAL EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN THE VENA CAVA FILTER AND THE FORMATION OF NEW DVT. THE RETRIEVAL DIFFICULTIES EXPERIENCED WERE DEFINED AS "TECHNICAL" AND WERE NOT FURTHER DELINEATED; THE ETIOLOGY IS UNKNOWN. VARIOUS COMPLICATIONS HAVE BEEN REPORTED WITH USE OF RETRIEVABLE IVC FILTERS. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL IMPOSSIBLE. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. INCORRECT ORIENTATION OF THE FILTER IS A KNOWN COMPLICATION FOR FILTER PLACEMENT AS INDICATED IN THE IFU. INABILITY TO SNARE THE HOOK FOR REMOVAL IS ANOTHER POTENTIAL COMPLICATION LISTED IN THE IFU THAT CAN BE RELATED TO USER PERFORMANCE. HOWEVER, WITH THE INFORMATION PROVIDED NO CONCLUSION CAN BE DRAWN BETWEEN THE FAILED RETRIEVAL ATTEMPTS AND THE DEVICE. PLEASE NOTE THAT THE EVENT DATE IS UNKNOWN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF ELEVEN PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2012-00677, 9616099-2012-00678, AND 9616099-2012-00679.
THIS LITERATURE ARTICLE KARMY-JONES ET AL PRACTICE PATTERNS AND OUTCOMES OF RETRIEVABLE VENA CAVA FILTERS IN TRAUMA PATIENTS: AN AAST MULTICENTER STUDY; THE JOURNAL OF TRAUMA_ INJURY, INFECTION, AND CRITICAL CARE 2007; 62:17-25; THE PURPOSE OF THIS STUDY IS TO DESCRIBE PRACTICE PATTERNS AND OUTCOMES OF POSTTRAUMATIC RETRIEVABLE INFERIOR VENA CAVAL FILTERS (R-IVCF). A RETROSPECTIVE REVIEW OF R-IVCFS PLACED DURING 2004 AT 21 PARTICIPATING CENTERS WITH FOLLOW UP TO JULY 1, 2005 WAS PERFORMED. PRIMARY OUTCOMES INCLUDED MAJOR COMPLICATIONS (MIGRATION, PULMONARY EMBOLISM [PE], AND SYMPTOMATIC CAVAL OCCLUSION) AND REASONS FOR FAILURE TO RETRIEVE. THE ARTICLE REPORTS THAT OF THE PATIENTS TREATED WITH THE OPTEASE VENA CAVA FILTER, THERE WERE ELEVEN ATTEMPTS MADE TO RETRIEVE THE FILTER, THREE WERE TECHNICALLY UNABLE TO BE REMOVED, FIVE HAD RESIDUAL THROMBUS AND FOUR HAD SYMPTOMATIC CAVAL OCCLUSION. THE MAJORITY WERE PLACED IN THE ANGIOGRAPHY SUITE BY INTERVENTIONAL RADIOLOGISTS. PLACEMENT OCCURRED 6 TO 8 DAYS AFTER ADMISSION AND RETRIEVAL WAS ATTEMPTED AT 50 TO 61 DAYS IN 116 (28%) CASES. THIS WAS NOT TECHNICALLY POSSIBLE IN 25 (22%) CASES EITHER BECAUSE OF TECHNICAL INABILITY OR DOCUMENTATION OF RESIDUAL THROMBUS IN THE IVC OR TRAPPED IN THE FILTERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26663 | UNKNOWN OPTEASE VENA CAVA FILTER | THROMBECTOMY SYSTEMS (DTK) | DTK | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |