466P306X
Report
- Report Number
- 1016427-2019-02576
- Event Type
- Injury
- Date Received
- March 1, 2019
- Date of Event
- November 26, 2013
- Report Date
- May 15, 2019
- Manufacturer
- CORDIS CASHEL
- Product Code
- DTK
- PMA / PMN Number
- K020316
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ADDITIONAL INFORMATION WAS RECEIVED FROM MEDICAL RECORDS THAT THE PATIENT¿S PREOPERATIVE DIAGNOSIS AT FILTER PLACEMENT WAS PULMONARY EMBOLI, LEFT POPLITEAL DEEP VEIN THROMBOSIS (DVT) AND SYNCOPE DURING AN EMERGENCY ADMISSION. THE DVT WAS FOUND IN THE LEFT LEG AND ALSO A LARGE SADDLE EMBOLISM WAS NOTED IN THE PULMONARY ARTERY EXTENDING TO ALL LOBAR AND SEGMENTAL BRANCHES BUT NO PULMONARY INFARCTION. THE PATIENT HAD A CARDIAC CATH AND WAS FOUND TO HAVE STENOSIS IN THE SAPHENOUS VEIN GRAFT. THE DECISION WAS MADE TO PLACE THE FILTER BEFORE THE CARDIAC PROCEDURE. ADDITIONAL MEDICAL HISTORY INCLUDED PRIOR CORONARY BYPASS SURGERY AND GUNSHOT WOUND TO HIS HEAD RESULTING IN HEMIPLEGIA. DURING THE EMERGENCY ADMISSION, A TRAPEASE VENA CAVA FILTER WAS PLACED APPROXIMATELY AT THE JUNCTION OF THE L2 AND L3. THERE WERE NO PROCEDURAL COMPLICATIONS. SUBSEQUENT TO THIS PROCEDURE, THE CARDIAC STENOSIS WAS TREATED WITH A DRUG ELUTING STENT. HE WAS INITIALLY ON A HEPARIN DRIP AND THEN ONCE MORE STABLE, HE WAS TRANSFERRED OVER TO XARELTO BY MOUTH WHEN TAKEN OFF THE HPARIN DRIP. POST PROCEDURE MEDICATIONS INCLUDED NEURONTIN 800 MG 3 TIMES A DAY, HYDROCODONEAS NEEDED FOR PAIN, SERTRALINE 150 MG A DAY, CLONAZEPAM 2 MG 3 TIMES A DAY AS NEEDED FOR ANXIETY, LOSARTAN 50 MG, A DAY, ASPIRIN 81 MG A DAY, COREG 25 MG TWICE A DAY, PRILOSEC 40 MG A DAY, XARELTO 50 MG B.I.D. WITH MEALS, AND SIMVASTATIN 40 MG AT BEDTIME. ADDITIONAL INFORMATION RECEIVED FROM A PATIENT PROFILE FORM (PPF) INDICATES THAT THE PATIENT SUFFERS FROM PAIN, STRESS AND ANXIETY.ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. ACCORDING TO THE INFORMATION PROVIDED THE PATIENT REPORTS PERFORATION OF FILTER STRUTS OUTSIDE THE INFERIOR VENA CAVA, TILT OF THE FILTER AND EXPERIENCING PAIN, STRESS AND ANXIETY. THE MEDICAL RECORDS INDICATED THAT THE PATIENT HAD A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, CORONARY ARTERY BYPASS SURGERY, CORONARY ARTERY DISEASE AND A GUNSHOT WOUND TO THE HEAD RESULTING IN LEFT SIDED HEMIPLEGIA. THE PATIENT ALSO EXPERIENCED A BLUNT INJURY APPROXIMATELY TEN MONTHS PRIOR TO THE FILTER IMPLANT AND SUSTAINED BLUNT ABDOMINAL TRAUMA AFTER FALLING AGAINST A FAN. PRIOR TO ADMISSION THE PATIENT HAD A SYNCOPAL EPISODE AND WAS DIAGNOSED WITH AN ACUTE MYOCARDIAL INFARCTION. THE INDICATION FOR THE FILTER IMPLANT WAS LARGE SADDLE PULMONARY EMBOLI EXTENDING TO ALL LOBAR AND SEGMENTAL BRANCHES OF THE PULMONARY ARTERY, BUT NO INFARCTION, LEFT LOWER LEG DEEP VEIN THROMBOSIS OF THE POPLITEAL VEIN AND A SYNCOPAL EPISODE. THE PATIENT HAD A CARDIAC CATHETERIZATION AND WAS FOUND TO HAVE STENOSIS IN THE SAPHENOUS VEIN GRAFT. THE DECISION WAS MADE TO PLACE THE FILTER BEFORE THE CARDIAC PROCEDURE. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND DEPLOYED AT APPROXIMATELY THE JUNCTION OF L2-L3. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. DURING THIS HOSPITALIZATION A DRUG ELUTING STENT WAS PLACED IN AN OCCLUDED SAPHENOUS VEIN GRAFT. THE PATIENT BECAME AWARE OF THE EVENTS APPROXIMATELY FIVE YEARS POST IMPLANT. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE FOR REVIEW. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE TRAPEASE VENA CAVA FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. 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. WITHOUT IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER TILT AND PERFORATION COULD NOT BE CONFIRMED, AND THE EXACT CAUSES COULD NOT BE DETERMINED. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOSITY. VESSEL PERFORATION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH IMPLANTING VENA CAVA FILTERS AND IS LISTED AS SUCH IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ALSO NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL AND LONG-TERM COMPLICATIONS RELATED TO IVC FILTERS. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PROCEDURAL FILMS OR POST IMPLANT IMAGES TO REVIEW THE REPORTED DEVICE PERFORATION OF THE INFERIOR VENA CAVA COULD NOT BE CONFIRMED OR FURTHER CLARIFIED. DUE TO THE NATURE OF THE COMPLAINT, THE REPORTED PAIN EXPERIENCED BY THE PATIENT COULD NOT BE CONFIRMED. PAIN AND ANXIETY DO NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT SPECIFIC ISSUES. GIVEN THE LIMITED INFORMATION CURRENTLY AVAILABLE FOR REVIEW, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENTS ARE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
INFORMATION CONTAINED IN THE MEDICAL RECORDS INDICATED THAT THE PATIENT HAD A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, CORONARY ARTERY BYPASS SURGERY, CORONARY ARTERY DISEASE AND A GUNSHOT WOUND TO THE HEAD RESULTING IN LEFT SIDED HEMIPLEGIA. THE PATIENT ALSO EXPERIENCED A BLUNT INJURY APPROXIMATELY TEN MONTHS PRIOR TO THE FILTER IMPLANT AND SUSTAINED BLUNT ABDOMINAL TRAUMA AFTER FALLING AGAINST A FAN. PRIOR TO ADMISSION THE PATIENT HAD A SYNCOPAL EPISODE AND WAS DIAGNOSED WITH AN ACUTE MYOCARDIAL INFARCTION. ACCORDING TO THE MEDICAL RECORDS THE INDICATION FOR THE FILTER IMPLANT WAS PULMONARY EMBOLI, LEFT POPLITEAL DEEP VEIN THROMBOSIS AND SYNCOPE. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND DEPLOYED AT APPROXIMATELY THE JUNCTION OF L2-L3. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. DURING THIS HOSPITALIZATION A DRUG ELUTING STENT WAS PLACED IN AN OCCLUDED SAPHENOUS VEIN GRAFT. ACCORDING TO THE PATIENT PROFILE FORM THE PATIENT REPORTS PERFORATION OF FILTER STRUTS OUTSIDE THE INFERIOR VENA CAVA, TILT OF THE FILTER AND EXPERIENCING PAIN, STRESS AND ANXIETY. THE PATIENT BECAME AWARE OF THE EVENTS APPROXIMATELY FIVE YEARS POST IMPLANT, ON (B)(6) 2018. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PHYSICAL AND EMOTIONAL DAMAGES FROM THE FILTER BEING TILTED AND PERFORATION OF THE FILTER. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE INFERIOR VENA CAVA (IVC) FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. 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. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER TILT AND PERFORATION OF THE IVC COULD NOT BE CONFIRMED. THE TIMING AND MECHANISM OF THE TILT HAS NOT BEEN REPORTED AT THIS TIME. THE BRIEF ALSO REPORTED A PERFORATION; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. IT IS UNKNOWN IF THE TILT CONTRIBUTED TO THE REPORTED PERFORATION. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PHYSICAL AND EMOTIONAL DAMAGES FROM THE FILTER BEING TILTED AND PERFORATION OF THE FILTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176850 | 466P306X | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CASHEL | 466P306X | 15897200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |