UNKNOWN OPTEASE VENA CAVA FILTER
Report
- Report Number
- 9616099-2014-00711
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- August 1, 2014
- Report Date
- October 15, 2014
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DTK
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THIS IS ONE OF SIX REPORTS ASSOCIATED WITH THE LITERATURE ARTICLE COMPLAINT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS: 9616099-2014-00711, 9616099-2014-00712, 9616099-2014-00713, 9616099-2014-00714, 9616099-2014-00715, & 9616099-2014-00716. ONE MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS (QUANTITY OF 1). THIS IS THE INITIAL AND FINAL REPORT FOR THIS COMPLAINT PRODUCT. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: ANDREOLI, J.M., LEWANDOWSKI R.J., VOGELZANG, R.L., RYU, R.K. (AUGUST 2014).COMPARISON OF COMPLICATION RATES ASSOCIATED WITH PERMANENT AND RETRIEVABLE INFERIOR VENA CAVA FILTERS: A REVIEW OF THE MAUDE DATABASE. J VASC INTERVENTIONAL RADIOLOGY, 25, 1181-1185. PLEASE NOTE THAT THE EVENT DATE ((B)(6) 2014) WAS PROVIDED INCORRECTLY IN ORDER TO MEET ELECTRONIC MEDWATCH ACCEPTANCE REQUIREMENTS. IT IS ONLY KNOWN THAT THE PUBLICATION DATE WAS IN AUGUST 2014; THE EXACT DAY IS UNKNOWN. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY ANDREOLI ET AL COMPARISON OF COMPLICATION RATES ASSOCIATED WITH PERMANENT AND RETRIEVABLE INFERIOR VENA CAVA FILTERS: A REVIEW OF THE MAUDE DATABASE,J VASC INTERVENTIONAL RADIOLOGY 25 (2014) 1181-1185; THERE WERE 9 FRACTURES, 26 MIGRATIONS, 6 FILTER TILTS, 2 CASES OF IVC PENETRATION, 1 CASE OF VENOUS THROMBOEMBOLISM/PULMONARY EMBOLISM, AND 7 CASES OF IVC THROMBUS, AND 33 PLACEMENT ISSUES IN THE OPTEASE GROUP. THE PURPOSE OF THE STUDY WAS TO COMPARE THE SAFETY OF PERMANENT AND RETRIEVABLE INFERIOR VENA CAVA (IVC) FILTERS BY REVIEWING THE U.S. FOOD AND DRUG ADMINISTRATION MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. THE MAUDE DATABASE WAS REVIEWED. PRODUCT CLASS SEARCH CRITERIA WERE ¿FILTER, INTRAVASCULAR, CARDIOVASCULAR.¿ TYPE OF DEVICE USED AND SPECIFIC ADVERSE EVENTS (AES) WERE RECORDED. OF REPORTED AES, 1,394 INVOLVED RETRIEVABLE INFERIOR VENA CAVA FILTERS (RIVCF¿S) AND 212 INVOLVED PERMANENT INFERIOR VENA CAVA FILTERS (PIVCF¿S). REPORTED AE¿S INCLUDED FRACTURE, MIGRATION, LIMB EMBOLIZATION, TILT, IVC PENETRATION, VENOUS THROMBOEMBOLISM AND PULMONARY EMBOLISM, IVC THROMBUS, AND MALFUNCTIONS DURING PLACEMENT. EACH SPECIFIC AE WAS REPORTED WITH SIGNIFICANTLY HIGHER FREQUENCY IN RIVCF¿S COMPARED WITH PIVCF¿S. THE MOST COMMON REPORTED COMPLICATION WITH RIVCFS WAS FRACTURE, WHEREAS THE MOST COMMONLY REPORTED COMPLICATIONS WITH PIVCF¿S WERE PLACEMENT MALFUNCTIONS. FOR RIVCFS, THE MOST COMMONLY REPORTED AE VARIED DEPENDING ON FILTER BRAND. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEWS COULD NOT BE PERFORMED. INFERIOR VENA CAVA FILTERS ARE USED TO PREVENT 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. CURRENT EVIDENCE INDICATES THAT IVC FILTERS ARE LARGELY EFFECTIVE; BREAKTHROUGH PE OCCURS IN ONLY 0% TO 6.2% OF CASES. COMPLICATIONS INCLUDE MISPLACEMENT OR EMBOLIZATION OF THE FILTER, VASCULAR INJURY OR THROMBOSIS, PNEUMOTHORAX, AND AIR EMBOLI. RECURRENT PE, IVC THROMBOSIS, FILTER MIGRATION, FILTER FRACTURE, OR PENETRATION OF THE CAVAL WALL SOMETIMES OCCUR WITH LONG-TERM USE. 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. WITH THE INFORMATION PROVIDED AND WITHOUT FILMS OF THE REPORTED EVENTS THERE IS NOT ENOUGH INFORMATION TO DRAW A DEFINITIVE CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENTS. 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.
AS NOTED IN THE PUBLICATION BY ANDREOLI ET AL COMPARISON OF COMPLICATION RATES ASSOCIATED WITH PERMANENT AND RETRIEVABLE INFERIOR VENA CAVA FILTERS: A REVIEW OF THE MAUDE DATABASE,J VASC INTERVENTIONAL RADIOLOGY 25 (2014) 1181-1185; THERE WERE 9 FRACTURES, 26 MIGRATIONS, 6 FILTER TILTS, 2 CASES OF IVC PENETRATION, 1 CASE OF VENOUS THROMBOEMBOLISM/PULMONARY EMBOLISM, AND 7 CASES OF IVC THROMBUS, AND 33 PLACEMENT ISSUES IN THE OPTEASE GROUP. THE PURPOSE OF THE STUDY WAS TO COMPARE THE SAFETY OF PERMANENT AND RETRIEVABLE INFERIOR VENA CAVA (IVC) FILTERS BY REVIEWING THE U.S. FOOD AND DRUG ADMINISTRATION MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. THE MAUDE DATABASE WAS REVIEWED. PRODUCT CLASS SEARCH CRITERIA WERE ¿FILTER, INTRAVASCULAR, CARDIOVASCULAR.¿ TYPE OF DEVICE USED AND SPECIFIC ADVERSE EVENTS (AES) WERE RECORDED. OF REPORTED AES, 1,394 INVOLVED RETRIEVABLE INFERIOR VENA CAVA FILTERS (RIVCF¿S) AND 212 INVOLVED PERMANENT INFERIOR VENA CAVA FILTERS (PIVCF¿S). REPORTED AE¿S INCLUDED FRACTURE, MIGRATION, LIMB EMBOLIZATION, TILT, IVC PENETRATION, VENOUS THROMBOEMBOLISM AND PULMONARY EMBOLISM, IVC THROMBUS, AND MALFUNCTIONS DURING PLACEMENT. EACH SPECIFIC AE WAS REPORTED WITH SIGNIFICANTLY HIGHER FREQUENCY IN RIVCF¿S COMPARED WITH PIVCF¿S. THE MOST COMMON REPORTED COMPLICATION WITH RIVCFS WAS FRACTURE, WHEREAS THE MOST COMMONLY REPORTED COMPLICATIONS WITH PIVCF¿S WERE PLACEMENT MALFUNCTIONS. FOR RIVCFS, THE MOST COMMONLY REPORTED AE VARIED DEPENDING ON FILTER BRAND. FDA-APPROVED PIVCFS INCLUDED PERCUTANEOUS GREEN- FIELD (STAINLESS STEEL AND TITANIUM; BOSTON SCIENTIFIC CORPORATION, (B)(4)), VENA TECH LGM AND LP(B. BRAUN MEDICAL, INC., (B)(4)), TRAPEASE(CORDIS ENDOVASCULAR ,CORDIS CORPORATION, (B)(4)) ,SIMON NITINOL (BARD PERIPHERAL VASCULAR, (B)(4)),AND BIRD¿S NEST (COOK, INC., (B)(4)). RIVCFS INCLUDED RECOVERY, G2, G2X, G2EXPRESS, ECLIPSE, AND MERIDIAN (ALL BARD PERIPHERAL VASCULAR); CELECT (COOK, INC.); OPTEASE (CORDIS ENDOVASCULAR, CORDIS CORPORATION); GUNTHER TULIP(COOK, INC.);OPTION (ARGON MEDICAL DEVICES, INC., (B)(4)); AND ALN (ALN INTERNATIONAL, (B)(4)). THE MAUDE DATABASE PROVIDES A SAMPLE OF SELF-REPORTED COMPLICATIONS ASSOCIATED WITH BOTH PIVCF¿S AND RIVCF¿S. BECAUSE THE TRUE PREVALENCE OF IVC FILTERS IN THE POPULATION IS UNKNOWN, OVERALL COMPLICATION RATES COULD NOT BE CALCULATED FROM THESE DATA. STATISTICAL ANALYSIS WAS PERFORMED WITH SPSS SOFTWARE. IN ADDITION TO THE EVENTS REPORTED ABOVE, THERE WERE 21 CASES OF ¿OTHER¿ AND 2 CASES OF LIMB EMBOLIZATION IN THE OPTEASE GROUP. THERE WERE 214 REPORTS OF IVC PENETRATION (DEFINED AS VISUALIZATION OF A FILTER ELEMENT > 3 CM BEYOND THE IVC LUMEN),82 (38.3%) OF WHICH WERE ASSOCIATED WITH PATIENT SYMPTOMS. OF CASES OF IVC PENETRATION, 28 (13.1%) PENETRATED INTO THE DUODENUM OR SMALL BOWEL, 14 (6.5%)PENETRATED INTO THE AORTA, AND 12(5.6%) PENETRATED INTO ADJACENT RETROPERITONEAL STRUCTURES SUCH AS THE VERTEBRAL BODIES AND DISKS. NINE CASES (4.2%) WERE ASSOCIATED WITH RETROPERITONEAL BLEEDS. FOR RIVCFS, THE MOST COMMON AE VARIED DEPENDING ON FILTER BRAND. FRACTURE WAS THE MOST COMMONLY REPORTED AE FOR BARD DEVICES (27.1%), IVC PENETRATION WAS THE MOST COMMONLY REPORTED AE FOR CELECT(29.9%), AND PLACEMENT MALFUNCTIONS WERE MOST COMMON FOR OPTEASE(30.8%) AND GUNTHER TULIP (45%). FOR PIVCFS, THE MOST COMMONLY REPORTED AES WERE MALFUNCTIONS DURING FILTER PLACEMENT, WHICH ACCOUNTED FOR 46.7% OF ALL COMPLICATIONS. FILTER MIGRATION (DEFINED AS MOVEMENT > 2 CM FROM INITIAL PLACEMENT) WAS THE NEXT MOST COMMON COMPLICATION FOR PIVCFS, ACCOUNTING FOR 27.1% OF AES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703261 | UNKNOWN OPTEASE VENA CAVA FILTER | THROMBECTOMY SYSTEMS (DTK) | DTK | CORDIS CORPORATION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |