COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2016-01102
- Event Type
- Injury
- Date Received
- September 22, 2016
- Date of Event
- January 1, 2015
- Report Date
- May 1, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K090140
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). F10) DEVICE CODE: UNINTENDED MOVEMENT (3026) LISTED IN THE IFU; DEVICE FRAGMENTS IN PATIENT (3165) NOT LISTED IN IFU. G1) NAME AND ADDRESS FOR IMPORTER SITE: (B)(6). REGISTRATION NO.: (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). ADDITIONAL INFORMATION: F10) DEVICE CODE: UNINTENDED MOVEMENT (3026) LISTED IN THE IFU; DEVICE FRAGMENTS IN PATIENT (3165) NOT LISTED IN IFU. G1) NAME AND ADDRESS FOR IMPORTER SITE: (B)(6). REGISTRATION NO.: (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113. INVESTIGATION - IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING 'CELECT, PE, FRACTURE, OCCLUDED, VC + ORGAN PERFORATION, UNABLE TO RETRIEVE (EMB'D), MIGRATION, TILT, PAIN '. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. FILTER FRACTURE IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. FRACTURE OF A FILTER LEG CAN BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL STRESSED POSITION. AMONG OTHER CAUSES, FILTER FRACTURE MAY BE ASSOCIATED WITH A FILTER LEG PERFORATING THE IVC, A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G. RENAL VEIN), EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G. A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND / OR PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. IT HAS BEEN REPORTED THAT RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS USING ENDOVASCULAR TECHNIQUES IS POSSIBLE. FRACTURE OF THE WIRE IS A KNOWN RISK IN RELATION TO AN IMPLANTED FILTER AND REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. IT IS KNOWN FROM THE PUBLISHED SCIENTIFIC LITERATURE THAT A FILTER FRAGMENT EMBOLIZED INTO THE HEART OR LUNG MAY BE SAFELY RETRIEVED. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS REPORTED THAT THE PULMONARY EMBOLISM IN SOME CASES MAY ORIGINATE FROM UPPER EXTREMITIES INSTEAD OF LOWER EXTREMITY VEINS. WITH ALL FILTERS, THERE IS SOME RISK OF FURTHER PULMONARY EMBOLISM. IVC THROMBOTIC OCCLUSION AS AN OUTCOME FOR COOK IVC FILTERS IS ADDRESSED IN THE PUBLISHED SCIENTIFIC LITERATURE. IVC THROMBOTIC OCCLUSION IS DEFINED AS THE PRESENCE OF AN OCCLUDING THROMBUS IN THE IVC AFTER FILTER INSERTION AND DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY; THIS MAY BE SYMPTOMATIC OR ASYMPTOMATIC. UNKNOWN IF THE REPORTED PAIN IS DIRECTLY RELATED TO THE FILTER. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. H3 OTHER TEXT : EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113. INVESTIGATION - IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING 'CELECT, PE, FRACTURE, OCCLUDED, VC + ORGAN PERFORATION, UNABLE TO RETRIEVE (EMB'D), MIGRATION, TILT, PAIN '. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. FILTER FRACTURE IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. FRACTURE OF A FILTER LEG CAN BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL STRESSED POSITION. AMONG OTHER CAUSES, FILTER FRACTURE MAY BE ASSOCIATED WITH A FILTER LEG PERFORATING THE IVC, A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G. RENAL VEIN), EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G. A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND / OR PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. IT HAS BEEN REPORTED THAT RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS USING ENDOVASCULAR TECHNIQUES IS POSSIBLE. FRACTURE OF THE WIRE IS A KNOWN RISK IN RELATION TO AN IMPLANTED FILTER AND REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. IT IS KNOWN FROM THE PUBLISHED SCIENTIFIC LITERATURE THAT A FILTER FRAGMENT EMBOLIZED INTO THE HEART OR LUNG MAY BE SAFELY RETRIEVED. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS REPORTED THAT THE PULMONARY EMBOLISM IN SOME CASES MAY ORIGINATE FROM UPPER EXTREMITIES INSTEAD OF LOWER EXTREMITY VEINS. WITH ALL FILTERS, THERE IS SOME RISK OF FURTHER PULMONARY EMBOLISM. IVC THROMBOTIC OCCLUSION AS AN OUTCOME FOR COOK IVC FILTERS IS ADDRESSED IN THE PUBLISHED SCIENTIFIC LITERATURE. IVC THROMBOTIC OCCLUSION IS DEFINED AS THE PRESENCE OF AN OCCLUDING THROMBUS IN THE IVC AFTER FILTER INSERTION AND DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY; THIS MAY BE SYMPTOMATIC OR ASYMPTOMATIC. UNKNOWN IF THE REPORTED PAIN IS DIRECTLY RELATED TO THE FILTER. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS ADDITIONAL INFORMATION RECEIVED ON 19MAR2018 AS FOLLOWS: ¿[PT] ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM, MOTORCYCLE CRASH. [PT] IS ALLEGING VENA CAVA PERFORATION, FRACTURE, PARTIAL FRAGMENT IRRETRIEVABLE. [PT] FURTHER ALLEGES PHYSICAL AND METAL DAMAGES, MIGRATION, TILT, FRACTURED LEAVING A PARTIAL STRUT NEAR SPINE CAUSING PAIN TO TESTICULAR AREA, LOWER ABDOMEN AREA, AND MID BACK, ABDOMINAL PAIN. FILTER REMOVAL WAS PERFORMED ON (B)(6) 2015 AND THE FILTER WAS REMOVED EXCEPT THE FRACTURED STRUT.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K09014, K112119 OR K121057. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: PATIENTS MEDICAL RECORDS ARE UNKNOWN AND NO IMAGING IS PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO COMMENT ON THE SIGNIFICANT PHYSICAL PERSONAL INJURIES, WHICH PATIENT ALLEGEDLY SUFFERED ALMOST 3 YEARS AFTER PLACEMENT OF A CELECT FILTER, BECAUSE THE FILTER BECAME "IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], CAUSING BLOOD CLOTS, BECOMING OCCLUDED, FAILING TO PREVENT A PULMONARY EMBOLISM AND/OR OTHERWISE BECOMING IRRETRIEVABLE OR RESULTING IN THE NEED FOR A COMPLICATED RETRIEVAL PROCEDURE." ALSO IT IS NOT POSSIBLE TO COMMENT ON "AS A DIRECT AND PROXIMATE RESULT OF THESE INJURIES, [PT] HAS INCURRED AND WILL INCUR MEDICAL EXPENSES IN THE FUTURE, HAS ENDURED AND WILL ENDURE PAIN AND SUFFERING AND LOSS OF ENJOYMENT OF LIFE, AND [PT] HAS OTHERWISE BEEN DAMAGED IN A PERSONAL AND PECUNIARY NATURE." FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING FILTER PLACEMENT OR DURING FILTER IMPLANTING PERIOD. UNDER NORMAL CONDITIONS, I.E. IVC < 30 MM, THE RADIAL FORCE OF THE FILTER WILL ENSURE PROPER ATTACHMENT OF THE FILTER LEGS TO IVC. HOWEVER, FILTER MIGRATION IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. MANIPULATION IN THE AREA OF THE FILTER IMPLANT OR A BLOOD CLOT CAPTURED INSIDE THE FILTER MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. IFU, CONTRAINDICATIONS: MEGACAVA (DIAMETER OF THE IVC > 30MM). FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FROM THE PUBLISHED SCIENTIFIC LITERATURE FILTER TILT INSIDE IVC AND/OR EMBEDMENT OF FILTER LEGS OR FILTER HOOK IN THE IVC WALL IS A WELL-KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. RPN AND LOT# ARE UNKNOWN, BUT THE TULIP FILTER IS MANUFACTURED/INSPECTED ACCORDING TO A41935/A41936. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K09014, K112119 OR K121057. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2012. ON OR AROUND (B)(6) 2015, [PT] SUFFERED SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE AFOREMENTIONED IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], CAUSING BLOOD CLOTS, BECOMING OCCLUDED, FAILING TO PREVENT A PULMONARY EMBOLISM AND/OR OTHERWISE BECOMING IRRETRIEVABLE OR RESULTING IN THE NEED FOR A COMPLICATED RETRIEVAL PROCEDURE." PATIENT OUTCOME: IT IS ALLEGED THAT "AS A DIRECT AND PROXIMATE RESULT OF THESE INJURIES, [PT] HAS INCURRED AND WILL INCUR MEDICAL EXPENSES IN THE FUTURE, HAS ENDURED AND WILL ENDURE PAIN AND SUFFERING AND LOSS OF ENJOYMENT OF LIFE, AND [PT] HAS OTHERWISE BEEN DAMAGED IN A PERSONAL AND PECUNIARY NATURE."
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2012. ON OR AROUND (B)(6) 2015, [PT] SUFFERED SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE AFOREMENTIONED IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], CAUSING BLOOD CLOTS, BECOMING OCCLUDED, FAILING TO PREVENT A PULMONARY EMBOLISM AND/OR OTHERWISE BECOMING IRRETRIEVABLE OR RESULTING IN THE NEED FOR A COMPLICATED RETRIEVAL PROCEDURE." PATIENT OUTCOME: IT IS ALLEGED THAT "AS A DIRECT AND PROXIMATE RESULT OF THESE INJURIES, [PT] HAS INCURRED AND WILL INCUR MEDICAL EXPENSES IN THE FUTURE, HAS ENDURED AND WILL ENDURE PAIN AND SUFFERING AND LOSS OF ENJOYMENT OF LIFE, AND [PT] HAS OTHERWISE BEEN DAMAGED IN A PERSONAL AND PECUNIARY NATURE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620858 | COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Life Threatening |