COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
Report
- Report Number
- 3002808486-2016-00011
- Event Type
- Injury
- Date Received
- January 13, 2016
- Date of Event
- December 15, 2015
- Report Date
- February 11, 2020
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K073374
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
MANUFACTURER REF# (B)(4). EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). WILLIAM COOK EUROPE IS NOT ASSUMING RESPONSIBILITY FOR PATIENT DEATH, UNCLEAR THE REASON FOR DEATH. (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. H11) CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: B1) ADVERSE EVENT TO ADVERSE EVENT AND PRODUCT PROBLEM. THE PATIENT INVOLVED WAS REPORTED TO BE DECEASED WITHOUT FURTHER DETAILS, THEREFORE THIS REPORT IS BEING SUBMITTED AS ¿DEATH¿ RELATED AS A CAUTIONARY MEASURE. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION. 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.
INVESTIGATION ¿ COMPLAINT REINVESTIGATED SINCE ADDITIONAL IMAGING WAS PROVIDED AND REVIEWED. IT WAS REPORTED THAT THE PATIENT DIED AS A RESULT OF EXSANGUINATION DUE TO ACUTE RETROPERITONEAL HEMORRHAGE CAUSED BY THROMBOEMBOLISM FILTER PIERCING INFERIOR VENA CAVA. HEAD CT FROM DATE OF FILTER PLACEMENT DEMONSTRATED POST-SURGICAL CHANGES STATUS POST RIGHT FRONTOTEMPORAL CRANIOTOMY. THERE IS SOME MIX DENSITY SUBDURAL FLUID THAT LIKELY REPRESENTS HEMORRHAGIC PRODUCTS OF UNCERTAIN CHRONICITY. THERE IS EVIDENCE OF BIFRONTAL ENCEPHALOMALCIA AND EX-VACU DILATATION OF THE RIGHT VENTRICLES, INDICATING CHRONIC CHANGES FROM PREVIOUS INJURY. CHEST CT WITH CONTRAST DEMONSTRATED LEFT LOWER LOBE AND RIGHT UPPER LOBE SEGMENTAL FILLING DEFECTS CONSISTENT WITH PULMONARY EMBOLI. THERE IS NO EVIDENCE OF RIGHT HEART STRAIN. CT SCAN OF ABDOMEN DEMONSTRATED NO ACUTE INTRAABDOMINAL PROCESS. INFERIOR VENA CAVAGRAM OF IVC FILTER PLACEMENT DEMONSTRATED ACCESS VIA THE LEFT COMMON FEMORAL VEIN WITH A SHEATH POSITIONED AT THE CONFLUENCE OF THE ILIAC VEINS. THIS DEMONSTRATES THE NORMAL INFLOW FROM THE RENAL VEINS. THE IVC MEASURES APPROXIMATELY 22MM IN THE INFRARENAL LOCATION. THE IVC ANATOMY IS NORMAL, ALTHOUGH THERE IS NO SCALE TO GIVE MEASUREMENTS. THE IVC IS SLIT LIKE IN CONFIGURATION WHICH MAY BE A PRODUCT OF PATIENT¿S OVERALL VOLUME STATUS. IN ADDITION, THE RIGHT EXTERNAL ILIAC VEIN IS DIMINUTIVE IN SIZE WHICH IS LIKELY A RESULT OF PREVIOUS THROMBOSIS, OR MUCH LESS LIKELY RELATED TO UNDER DISTENTION FROM POOR INFLOW FROM THE RIGHT LEG. ULTRASOUND OF BILATERAL LOWER EXTREMITIES DEMONSTRATED NON-OCCLUSIVE THROMBUS IN THE RIGHT COMMON FEMORAL VEIN AND PROXIMAL RIGHT SUPERFICIAL FEMORAL VEIN. THERE IS ALSO NON-OCCLUSIVE THROMBUS IN THE DISTAL LEFT SUPERFICIAL FEMORAL VEIN. THERE IS POOR RESPIRATORY VARIABILITY SEEN IN THE RIGHT DEEP VENOUS SYSTEM DUE TO THE PROXIMAL THROMBUS AND ATRETIC RIGHT EXTERNAL ILIAC VEIN. ULTRASOUND OF BILATERAL UPPER EXTREMITIES TWO DAYS AFTER FILTER PLACEMENT DEMONSTRATED BILATERAL UPPER EXTREMITY DVTS INVOLVING THE RIGHT DISTAL BRACHIAL VEIN, AND LEFT DISTAL BRACHIAL VEIN WITH EXTENSION INTO THE CEPHALIC VEIN. AUTOPSY IMAGES DEMONSTRATED A LARGE RETROPERITONEAL HEMORRHAGE EXTENDING INTO THE ROOT OF THE MESENTERY. FURTHER DISSECTION OF THE IVC DEMONSTRATES THE IVC FILTER IN THE IVC WHICH HAS BEEN OPENED LONGITUDINALLY. ON THE IMAGES PROVIDED, THERE IS SIGNIFICANT ENDOTHELIZATION OF 3 PRIMARY FILTER LEGS AND 5 SECONDARY FILTER LEGS. THERE IS DEMONSTRATION OF FRANK PERFORATION OF AT LEAST ONE OF A PRIMARY FILTER LEG THROUGH THE WALL OF THE IVC. IT IS DIFFICULT TO DETERMINE, BUT THERE MAY BE FRANK PERFORATION INVOLVING 2 ADDITIONAL PRIMARY FILTER LEGS, HOWEVER THE IMAGES ARE ANNOTATED TO HELP DETERMINE THE ORIENTATION OF EACH VIEW. THERE ARE IMAGES DEMONSTRATING A SECONDARY FILTER LEG EXTENDING THROUGH THE WALL OF THE IVC. THERE IS INCORPORATION OF THE IVC FILTER HOOK INTO THE WALL OF THE IVC, BUT NOT FRANKLY PENETRATING THROUGH THE WALL ON THE IMAGES SUBMITTED. THERE IS A LARGE AMOUNT OF HEMORRHAGE IN THE SURROUNDING RETROPERITONEAL SOFT TISSUES. THE CELECT FILTER WAS PLACED FROM FEMORAL APPROACH IN THE INFRARENAL LOCATION WITH A 12 DEGREE LEFTWARD TILT. IN ADDITION, AT LEAST ONE SECONDARY FILTER LEG IS ORIENTED PERPENDICULAR TO THE LONG ACCESS OF THE IVC FILTER AND DIRECTED TOWARDS THE RIGHT WALL OF THE IVC. THIS SECONDARY FILTER LEG EXTENDS 6MM OUTSIDE OF THE COLUMN OF CONTRAST INDICATING PENETRATION. THE MOST LIKELY EXPLANATION FOR THIS APPEARANCE IS THE FILTER WAS MOVED CAUDALLY AFTER EXPOSING THE SECONDARY FILTER LEGS, ALLOWING ONE OF THE SECONDARY LEGS TO ENGAGE WITH THE WALL OF THE IVC AND ALTER ITS ORIENTATION. THE IFU STATES THE FILTER CANNOT BE ¿PULLED BACK¿ AFTER THE SECONDARY LEGS ARE EXPOSED. ALTHOUGH THE PROCEDURE REPORT FROM THE IVC FILTER PLACEMENT DOES NOT ELABORATE ON WHAT OCCURRED NEXT, THERE IS A CHANGE IN ORIENTATION OF THE SECONDARY LEGS BETWEEN THE INITIAL PLACEMENT IMAGES AND THE FINAL IMAGE OBTAINED. A REPEAT VENOGRAM WITH MAGNIFIED VIEWS OF THE FILTER DEMONSTRATE SLIGHT CHANGE IN POSITION OF THE SECONDARY LEGS ALTHOUGH NO SIGNIFICANT CHANGE IN FILTER TILT. THE RIGHTWARD DIRECTED SECONDARY LEG HAS NOW CHANGED IN ORIENTATION AND IS ORIENTED MORE CAUDAL, LESS THAN PERPENDICULAR TO THE LONG ACCESS OF THE IVC FILTER. THE AMOUNT OF PENETRATION HAS ALSO DECREASED, NOW EXTENDING LESS THAN 3 MM OUTSIDE THE COLUMN OF CONTRAST. THERE IS ALSO NOW A SECOND SECONDARY FILTER LEG ORIENTATED ~70 DEGREE ANGLE RELATIVE TO THE LONG ACCESS OF THE IVC FILTER. THIS LEG CAUSES MILD TENTING OF THE WALL OF THE IVC BUT DOES NOT RESULT IN PENETRATION. ON THE INITIAL IMAGE, ONLY ONE MISALIGNED SECONDARY LEG WAS APPRECIATED. THE PATIENT UNFORTUNATELY PRESENTED 5 MONTHS LATER, ESSENTIALLY EXSANGUINATING INTO THE RETROPERITONEAL (RP) SPACE. THE CORONER ATTRIBUTES THIS RP BLEED TO THE OBSERVED FILTER LEG PENETRATIONS FOUND AT TIME OF AUTOPSY. THE CELECT FILTER WAS PLACED FOR LOWER EXTREMITY DVT AND CONTRAINDICATION TO ANTICOAGULATION. HOWEVER, IN THE MEDICAL RECORDS, AT THE TIME OF DIAGNOSIS OF PULMONARY EMBOLISM AND DVT, THE RECORDS INDICATED THAT ANTICOAGULATION WAS INITIATED WITH THE FAMILY UNDERSTANDING THE INCREASED RISK OF INTRACRANIAL HEMORRHAGE GIVEN THE PREVIOUS TRAUMA AND SURGERY. THERE IS A NOTE DOCUMENTING NEUROSURGERY¿S APPROVAL TO START ANTICOAGULATION FOR TREATMENT OF PULMONARY EMBOLISM WITH CLOSE INTERVAL FOLLOW-UP WITH A HEAD CT SCAN PERFORMED THE NEXT DAY DEMONSTRATING STABLE FINDINGS.THERE IS NO DISCUSSION OF THE PATIENT¿S ANTICOAGULATION STATUS AT THE PRESENTATION, BUT GIVEN HE WAS STARTED ON ANTICOAGULATION 5 MONTHS PRIOR, HE MAY HAVE BEEN ANTICOAGULATED AT THE TIME OF THE RP BLEED, WHICH INEVITABLY CONTRIBUTED TO THE BLEEDING EVENT. DETERMINING THE STRONGEST CONTRIBUTING FACTOR TO THE DEVELOPMENT OF PENETRATION IS NOT DEFINITE. HOWEVER, GIVEN THE INITIAL TILT, MISALIGNED SECONDARY FILTER LEGS DUE TO IMPROPER DEPLOYMENT AND LIKELY ATTEMPTS TO CORRECT THIS MISALIGNMENT, THESE FACTORS WERE POTENTIALLY THE PREDOMINANT CAUSE OF THE PENETRATION AS THEY CREATED ABNORMAL AND ASYMMETRIC FORCES BETWEEN THE IVC FILTER LEGS AND THE WALL OF THE IVC. HOWEVER, IN THIS CASE, THE PERFORATIONS APPEAR TO HAVE DIRECTLY CONTRIBUTED TO THE DEVELOPMENT OF THE RP BLEED. IMPORTANTLY, AND NOT APPARENTLY DISCUSSED IN THE REVIEWED MEDICAL RECORDS, IS THE ABSENCE OF THE CLINICAL NEED FOR THE IVC FILTER TO STILL BE PRESENT. THE INITIAL INDICATION FOR IVC FILTER PLACEMENT WAS NOT APPARENT, NOR WAS THE CONTINUED NEED FOR ITS PRESENCE. 20 DEVICES IN LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO CURRENT CONTROLS. IT WAS DETERMINED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(6) (IMPORTER). NAME AND ADDRESS FOR IMPORTER SITE: (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.
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 "CELECT - VC PERFORATION CAUSING BLEEDING, DEATH, EMBEDMENT, RETROPERITONEAL HEMORRHAGE - UPDATED SFC." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. AUTOPSY REPORT CONFIRMED THE DEATH OF THE PATIENT RELATED TO THE FILTER. 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. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. UNKNOWN IF THE REPORTED RETROPERITONEAL HEMORRHAGE AND BLEEDING ARE DIRECTLY RELATED TO THE FILTER. NO RELEVANT NOTES ON NEITHER DEVICE OR LOT NUMBER. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED. 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
MANUFACTURER REF# (B)(4). EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). WILLIAM COOK EUROPE IS NOT ASSUMING RESPONSIBILITY FOR PATIENT DEATH, UNCLEAR THE REASON FOR DEATH. IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH COOK CELECT FILTER ON (B)(6) 2013 AT THE UNIVERSITY MEDICAL CENTER OF (B)(6). THE CELECT FILTER WAS PROPERLY DEPLOYED AND CONFIRMED TO BE IN "GOOD POSITION" AFTER PLACEMENT. THE DEVICE SUBSEQUENTLY FAILED AND TORE MULTIPLE HOLES IN VENA CAVA RESULTING IN MASSIVE INTERNAL BLEEDING AND DEATH ON (B)(6) 2015. AN AUTOPSY CONFIRMED THAT [PT] BLED TO DEATH AS A RESULT OF THE FILTER PIERCING HIS VENA CAVA, WHICH LED TO MASSIVE INTERNAL BLEEDING FROM HIS VENA CAVA". IT IS ALLEGED THAT "[PT] BLED TO DEATH AS A RESULT OF THE FILTER PIERCING HIS VENA CAVA, WHICH LED TO MASSIVE INTERNAL BLEEDING FROM HIS VENA CAVA". 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. 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. HOWEVER, WITHOUT IMAGING AND ONLY LIMITED INFORMATION AVAILABLE, IT IS IMPOSSIBLE TO COMMENT ON THE ALLEGED PERFORATION AND CONSEQUENTLY DEATH. 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.
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. 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 . ADDITIONAL INFORMATION: INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. 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 ¿VC PERFORATION CAUSING BLEEDING, DEATH". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. UNKNOWN IF REPORTED PATIENT DEATH IS RELATED TO FILTER. 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 CELECT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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 WAS RECEIVED ON 04/05/2016 AS FOLLOWS: THE PATIENT ALLEGEDLY RECEIVED THE FILTER IMPLANT VIA LEFT INTERNAL JUGULAR VEIN ON (B)(6) 2013. THE DEVICE ALLEGEDLY SUBSEQUENTLY FAILED AND ALLEGEDLY TORE MULTIPLE HOLES IN VENA CAVA RESULTING IN MASSIVE INTERNAL BLEEDING AND DEATH ON (B)(6) 2015. AN AUTOPSY REPORTED THAT THE PATIENT BLED TO DEATH AS A RESULT OF THE FILTER PIERCING HIS VENA CAVA, WHICH LED TO MASSIVE INTERNAL BLEEDING FROM HIS VENA CAVA.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT PER THE (B)(6) 2013, AUTOPSY REPORT: "OPINION: CAUSE OF DEATH: IT IS MY OPINION THAT THIS 55-YEAR-OLD WHITE MALE, DIED AS A RESULT OF EXSANGUINATION DUE TO ACUTE RETROPERITONEAL HEMORRHAGE DUE TO THROMBOEMBOLISM FILTER PIERCING INFERIOR VENA CAVA. A SIGNIFICANT CONTRIBUTING CONDITION IS BLUNT HEAD TRAUMA DUE TO ASSAULT. MANNER OF DEATH: HOMICIDE. INVENTORY OF SIGNIFICANT FINDINGS: 1. THE RETROPERITONEAL SOFT TISSUE (BILATERAL AND GREATER ON THE LEFT SIDE, WITH EXTENSION INTO THE LEFT PSOAS MUSCLE, THE PERICYSTIC SOFT TISSUES AND THE LEFT PELVIC SOFT TISSUE) DEMONSTRATES A BROAD AREA OF HEMORRHAGE ASSOCIATED WITH SCATTERED HEMATOMA FORMATION; DISSECTION OF THE AREA DEMONSTRATES AN INFERIOR VENA CAVA THROMBOEMBOLISM FILTER (MODIFIED GREENFIELD TYPE) EXHIBITING EIGHT PRONGS WITH SIX OF THE EIGHT PRONGS EMBEDDED/PENETRATING THE WALL OF THE INFERIOR VENA CAVA; FURTHER DISSECTION DEMONSTRATES THAT FOUR OF THE SIX EMBEDDED/PENETRATING PRONGS PIERCE THE WALL OF THE INFERIOR VENA CAVA AND THREE OF THE FOUR PIERCING PRONGS ARE ASSOCIATED WITH PERICAVAL HEMORRHAGE, ESPECIALLY PRONG ADJACENT TO THE OSTIUM OF THE LEFT RENAL VEIN; THE BLOOD LOSS CANNOT BE EXACTLY QUANTITATED, HOWEVER VISUALLY THE BLOOD LOSS IS ESTIMATED TO BE 1500-2500ML; DISSECTION OF THE OTHER VASCULAR STRUCTURES AND ORGANS IN THE AREA SHOW EVIDENCE OF INJURY".
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
(B)(4) CATALOG# UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERED TO AS A COOK CELECT FILTER. LOT# UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. AS CATALOG# IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. SUMMARY OF INVESTIGATIONAL FINDINGS: 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. HOWEVER, WITHOUT IMAGING AND ONLY LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO COMMENT ON THE ALLEGED PERFORATION AND CONSEQUENTLY DEATH. 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 AS INFORMATION WAS NOT PROVIDED BUT REFERED TO AS A COOK CELECT FILTER. LOT# UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. AS CATALOG# IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH COOK CELECT FILTER ON (B)(6) 2013 AT THE UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA. THE CELECT FILTER WAS PROPERLY DEPLOYED AND CONFIRMED TO BE IN "GOOD POSITION" AFTER PLACEMENT. THE DEVICE SUBSEQUENTLY FAILED AND TORE MULTIPLE HOLES IN VENA CAVA RESULTING IN MASSIVE INTERNAL BLEEDING AND DEATH ON (B)(6) 2015. AN AUTOPSY CONFIRMED THAT [PT] BLED TO DEATH AS A RESULT OF THE FILTER PIERCING HIS VENA CAVA, WHICH LED TO MASSIVE INTERNAL BLEEDING FROM HIS VENA CAVA." PATIENT OUTCOME: IT IS ALLEGED THAT "[PT] BLED TO DEATH AS A RESULT OF THE FILTER PIERCING HIS VENA CAVA, WHICH LED TO MASSIVE INTERNAL BLEEDING FROM HIS VENA CAVA."
DESCRIPTION ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH COOK CELECT FILTER ON (B)(6) 2013 AT THE UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA. THE CELECT FILTER WAS PROPERLY DEPLOYED AND CONFIRMED TO BE IN "GOOD POSITION" AFTER PLACEMENT. THE DEVICE SUBSEQUENTLY FAILED AND TORE MULTIPLE HOLES IN VENA CAVA RESULTING IN MASSIVE INTERNAL BLEEDING AND DEATH ON (B)(6) 2015. AN AUTOPSY CONFIRMED THAT [PT] BLED TO DEATH AS A RESULT OF THE FILTER PIERCING HIS VENA CAVA, WHICH LED TO MASSIVE INTERNAL BLEEDING FROM HIS VENA CAVA." PATIENT OUTCOME: IT IS ALLEGED THAT "[PT] BLED TO DEATH AS A RESULT OF THE FILTER PIERCING HIS VENA CAVA, WHICH LED TO MASSIVE INTERNAL BLEEDING FROM HIS VENA CAVA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23742 | COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E3032069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Death |