UNKNOWN OPTEASE VENA CAVA FILTER
Report
- Report Number
- 9616099-2014-00712
- 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
- Product Problem
- 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 26). 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 KNOW 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. IVC FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE IFU AS SUCH. INTRACARDIAC MIGRATION OF IVC FILTERS IS A RARE BUT POTENTIALLY FATAL EVENT. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDES MEGA CAVA (IVC DIAMETER >28 MM), WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, ¿SAIL¿ EFFECT (CRANIAL MIGRATION) OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO THE FRACTURE AND MIGRATION OF IVC FILTERS. PHYSIOLOGIC CAUSES OF MIGRATION MAY RESULT FROM TEMPORARY DYSMORPHISM OF THE INFERIOR VENA CAVA INCLUDING BENDING, COUGHING OR VALSALVA MANEUVERS RESULTING IN DISLODGMENT OF THE FILTER. MIGRATION OF IVC FILTERS HAS BEEN DEMONSTRATED WHEN THE PRESENCE OF AN OVERBURDEN OF THROMBUS IN THE VASCULATURE OCCURS THAT EXCEEDS THE DEVICES ABILITY TO EXERT RADIAL FORCE TOWARD THE VESSEL WALLS AND MAINTAIN OPTIMAL POSITIONING AND IN PATIENTS WHO WERE IN A DEHYDRATED STATE WHEN THE FILTER WAS PLACED AND HAVE SINCE RE-HYDRATED THEREBY EXPANDING THE DIAMETER OF THE VENA CAVA. 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 |
|---|---|---|---|---|---|---|---|
| 703827 | UNKNOWN OPTEASE VENA CAVA FILTER | THROMBECTOMY SYSTEMS (DTK) | DTK | CORDIS CORPORATION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |