466FXXXX
Report
- Report Number
- 1016427-2018-02277
- Event Type
- Injury
- Date Received
- November 19, 2018
- Date of Event
- January 1, 2018
- Report Date
- April 25, 2019
- Manufacturer
- CORDIS CASHEL
- Product Code
- DTK
- PMA / PMN Number
- K034050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FROM (PPF), THE PATIENT BECAME AWARE OF THE REPORTED EVENTS EIGHT YEARS AND ELEVEN MONTHS POST IMPLANTATION. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE IVC, AND UNABLE TO BE RETRIEVED. AN UNSUCCESSFUL FILTER RETRIEVAL ATTEMPT WAS MADE NINETEEN DAYS POST IMPLANTATION. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS STATE THAT THE PATIENT WAS PRESENTED WITH EXTENSIVE TRAUMA WITH MULTIPLE FACIAL AND CERVICAL SPINE FRACTURES AS WELL AS FRACTURED RIBS AND PARENCHYMAL CONTUSIONS. AN IVC FILTER PLACEMENT WAS REQUESTED DUE TO AN EXPECTED PROLONGED HOSPITAL COURSE. DURING THE IMPLANT PROCEDURE, THE RIGHT COMMON FEMORAL VEIN WAS ACCESSED AND A 0.018 GUIDEWIRE WAS ADVANCED. A 0.035 BENSON WIRE WAS ADVANCED INTO THE IVC AND THE IV WAS DEPLOYED IN THE INFRARENAL INFERIOR VENA CAVA. THE PATIENT TOLERATED THE PROCEDURE WELL.
A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT R1108035 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. CORRECTED DATA: CATALOG NUMBER: 466F220A, LOT NUMBER: R1108035, UNIQUE IDENTIFIER (UDI) # (B)(4). PMA/510(K)NUMBER K034050. DEVICE MANUFACTURE DATE: NOVEMBER 5, 2008. METHOD CODE 3331 ANALYSIS OF PRODUCTION RECORDS.
IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THERE WERE BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC), AND THE FILTER WAS UNABLE TO BE RETRIEVED. THE INDICATION FOR THE FILTER IMPLANT WAS EXTENSIVE TRAUMA WITH MULTIPLE FACIAL AND CERVICAL SPINE FRACTURES AS WELL AS FRACTURED RIBS AND PARENCHYMAL CONTUSIONS AND AN ANTICIPATED PROLONGED HOSPITAL COURSE. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND DEPLOYED IN THE INFRARENAL IVC. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL WITH NO PROCEDURAL COMPLICATIONS. APPROXIMATELY NINETEEN DAYS LATER THE PATIENT UNDERWENT AN UNSUCCESSFUL PERCUTANEOUS ATTEMPT TO RETRIEVE THE FILTER DUE TO THE PRESENCE OF THROMBUS. 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 OPTEASE 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 OPTEASE VENA CAVA FILTER IS INDICATED IN THE US FOR RETRIEVAL UP TO 14 DAYS POST IMPLANTATION. FOLLOWING THIS PERIOD OF TIME, AND AS EARLY AS 12 DAYS, THERE IS POTENTIAL FOR ENDOTHELIALIZATION (GROWTH OF ENDOTHELIAL CELLS WITHIN THE INNER WALL OF THE VESSEL) AROUND THE FILTER STRUTS. 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. BLOOD CLOTS, CLOTTING AND OCCLUSION OF THE IVC DO NOT REPRESENT A DEVICE MALFUNCTION, RATHER CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENTS INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. STANDARD OF CARE DICTATES THAT A FILTER SHOULD NOT BE DISRUPTED IF THROMBUS IS PRESENT TO MITIGATE THE RISK OF PULMONARY EMBOLISM ASSOCIATED WITH A REMOVAL ATTEMPT. THERE IS NOTHING IN THE REPORTED INFORMATION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, AS SUCH NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE, INCLUDING, BUT NOT LIMITED TO UNABLE TO REMOVE FILTER DUE TO THROMBUS IN FILTER. AS A DIRECT AND PROXIMATE RESULT, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE FOR REVIEW. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE STERILE LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. THE OPTEASE 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 OPTEASE VENA CAVA FILTER IS INDICATED IN THE US FOR RETRIEVAL UP TO 14 DAYS POST IMPLANTATION. FOLLOWING THIS PERIOD OF TIME, AND AS EARLY AS 12 DAYS, THERE IS POTENTIAL FOR ENDOTHELIALIZATION (GROWTH OF ENDOTHELIAL CELLS WITHIN THE INNER WALL OF THE VESSEL) AROUND THE FILTER STRUTS. 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. BLOOD CLOTS, CLOTTING AND OCCLUSION OF THE IVC DO NOT REPRESENT A DEVICE MALFUNCTION, RATHER CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENTS INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. THERE IS NOTHING IN THE REPORTED INFORMATION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, AS SUCH NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY. PLEASE NOTE THAT DEVICE REPORTED IS AN OPTEASE VENA CAVA FILTER AND FOR WHICH THE CATALOG AND LOT NUMBERS ARE NOT CURRENTLY AVAILABLE. IF OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE, INCLUDING, BUT NOT LIMITED TO UNABLE TO REMOVE FILTER DUE TO THROMBUS IN FILTER. AS A DIRECT AND PROXIMATE RESULT, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 925586 | 466FXXXX | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CASHEL | R1108035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Life Threatening| S |