COOK CELECT FEMORAL VENA CAVA FILTER SET

Report

Report Number: 3002808486-2011-00031
Event Type: Injury
Date Received: August 19, 2011
Date of Event: August 17, 2011
Report Date: May 22, 2019
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
PMA / PMN Number: K073374
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: WV, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THE EVALUATION WAS PERFORMED ON A MEETING WITH PARTICIPATION OF THE PRODUCT MANAGER, THE MEDICAL ADVISER AND THE QUALITY ENGINEER. THE EVALUATION OF THIS COMPLAINT WAS BASED ON THE DESCRIPTION ONLY SINCE IT HAS NOT BEEN POSSIBLE TO OBTAIN ANY ADDITIONAL INFORMATION, IMAGES OR DEVICE (ANONYMOUS REPORTER). ACCORDING TO THE DESCRIPTION, IT WAS NOTED THAT THE FILTER PERFORATED IVC AND THE FILTER LEGS EXTENDED INTO THE AORTA, ABDOMEN AND THE SPINE. IF IT WAS PRIMARY OR SECONDARY FILTER LEGS ARE UNKNOWN. THE PATIENT WAS TOLD THAT ATTEMPTED RETRIEVAL COULD CAUSE DEATH OR MORE SERIOUS DISABILITIES. ALSO, THE PATIENT EXPERIENCED BACKPAIN AND ABDOMINAL PAIN. IT IS POSSIBLE THAT THE FILTER LEGS ARE PRESSING ON SURROUNDING NERVES, CAUSING THE PAIN. IT IS NOT POSSIBLE TO DETERMINE IF THE FILTER ACTUALLY DID PERFORATE IVC WITHOUT IMAGES. IT HAS NOT BEEN POSSIBLE TO OBTAIN ADDITIONAL INFORMATION, AND WE DO NOT KNOW THE CURRENT STATUS OF THE PATIENT. ALSO, FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. DESPITE PERFORATION THEY ALL END UP IN SUCCESSFUL FILTER RETRIEVAL. NO OTHER COMPLAINTS RECEIVED ON THIS LOT NUMBER. NOTHING FURTHER IS INITIATED SINCE THE DESCRIPTION AND THE IMAGES DO NOT INDICATE PRESENCE OF DEVICE FAILURE.

Additional Manufacturer Narrative · 1

(B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: NO SELECTION TO PRODUCT MALFUNCTION, SERIOUS INJURY TO MALFUNCTION. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

Additional Manufacturer Narrative · 1

EXEMPTION NUMBER E2016032 . WILLIAM COOK (B)(4) APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). (B)(4). ADDITIONAL INFORMATION: 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 "TILT, ORGAN/VC PERFORATION, BLEEDING, BURNING SENSATION IN CHEST, DEEP UPPER QUADRANT PAIN." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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. 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. UNKNOWN IF THE REPORTED BLEEDING, BURNING SENSATION IN CHEST, AND DEEP UPPER QUADRANT PAIN ARE DIRECTLY RELATED TO THE FILTER. A TOTAL OF 10 DEVICES WERE MANUFACTURED IN THE REPORTED LOT. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THIS LOT. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO CURRENT CONTROLS. 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.

Additional Manufacturer Narrative · 1

EXEMPTION NUMBER E2016032. WILLIAM COOK (B)(4) APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Additional Manufacturer Narrative · 1

EXEMPTION NUMBER E2016032. WILLIAM COOK (B)(4) APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REFERENCE # (B)(4). 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 'TILT, VENA CAVA PERFORATION, BLEEDING, BURNING SENSATION IN CHEST, DEEP UPPER QUADRANT PAIN '. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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 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. 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.

Description of Event or Problem · 1

AS REPORTED TO THE FDA#: (B)(4): CONSTANT CHRONIC PAIN IN BACK AND ABDOMEN APPEARING AS PAIN FROM RENAL OR GALLSTONES BUT NONE EVER DETECTED. IT WAS NOTED THAT A WIRE FROM COOK CELECT IVC FILTER WAS PROTRUDING INTO AORTA, BUT NOTING NOTED AS TO WIRES INTO OTHER AREAS. SPINE AND ABDOMEN AREA WIRES WERE DETECTED AT ANOTHER MEDICAL FACILITY, BUT WAS HASTILY DISCHARGED. HAVE BEEN INFORMED THAT THE ATTEMPTED REMOVAL CAN CAUSE DEATH OR MORE SERIOUS DISABILITIES. NOT HAVING THE IVC FILTER REMOVED WITH HAVE A CATASTROPHIC OUTCOME. ONE DAY TO FIVE YEARS... FROM THE INFORMATION PROVIDED BY THE REPORTER, A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

Description of Event or Problem · 1

THIS ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2009 VIA THE LEFT FEMORAL VEIN AFTER THE PATIENT HAD UNDERGONE BRAIN SURGERY FOR CEREBRAL BLEEDING DUE TO PE AND DVT. PLAINTIFF IS ALLEGING TILT, VENA CAVA PERFORATION, BLEEDING, BURNING SENSATION IN CHEST, AND DEEP UPPER QUADRANT PAIN AND PRESSURE. PATIENT ALLEGES SUCCESSFUL RETRIEVAL ON (B)(6) 2011.

Description of Event or Problem · 1

NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

Description of Event or Problem · 1

PER COMPUTED TOMOGRAPHY SPINE LUMBAR WITHOUT CONTRAST, (B)(6) 2011, : "FINDINGS: EVALUATION OF THE SOFT TISSUES REDEMONSTRATES SUGGESTION OF AN INFERIOR VENA CAVA FILTER LEG WITHIN THE AORTIC LUMEN".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COOK CELECT FEMORAL VENA CAVA FILTER SET	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	WILLIAM COOK EUROPE	N/A	E2356817

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Life Threatening