FDA Adverse Event Injury Summary report: N

COOK CELECT JUGULAR VENA CAVA FILTER SET

MDR report key: 6943326 · Received October 12, 2017

Report

Report Number: 3002808486-2017-01953
Event Type: Injury
Date Received: October 12, 2017
Report Date: July 1, 2020
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
PMA / PMN Number: K073374
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). 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.

Additional Manufacturer Narrative · 0

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 ¿MIGRATION, TILT, VC & ORGAN PERFORATION, ANXIETY, STRESS". 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 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. UNKNOWN IF THE REPORTED ANXIETY, STRESS IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. NO OTHER COMPLAINTS FOUND ON LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO MANUFACTURING INSTRUCTIONS. 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 . 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 ¿MIGRATION, TILT, VC & ORGAN PERFORATION, ANXIETY, STRESS". 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 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. UNKNOWN IF THE REPORTED ANXIETY, STRESS IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. NO OTHER COMPLAINTS FOUND ON LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO MANUFACTURING INSTRUCTIONS. 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.

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER E2016032E LOT. (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 · 0

MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT WAS REOPENED FOR INVESTIGATION SINCE IMAGING WAS PROVIDED AND REVIEWED. A CELECT IVC FILTER WAS DEPLOYED IN INFRARENAL LOCATION WITH APPROXIMATELY 4° OF RIGHTWARD TILT, BUT WITHOUT EVIDENCE OF IMMEDIATE PENETRATION. X-RAYS DATED APPROX. TWO MONTHS LATER DEMONSTRATED SLIGHT INTERVAL INCREASE IN RIGHTWARD TILT, NOW MEASURING APPROX. 11°, BUT ALL PRIMARY AND SECONDARY LEGS APPEAR NORMALLY ALIGNED. ULTRASOUND DATED APPROX. THREE MONTHS AFTER PLACEMENT DEMONSTRATED THROMBOSIS OF RIGHT FEMORAL VEIN. ON THE LEFT, THERE IS THROMBUS SEEN WITHIN THE LEFT COMMON FEMORAL VEIN, BUT THE REMAINING VISUALIZED PORTIONS OF THE DEEP VENOUS SYSTEM APPEAR PATENT. ULTRASOUND DATED ONE YEAR LATER DEMONSTRATED WHAT APPEARED TO BE RESIDUAL THROMBUS WITHIN THE MIDPORTION OF THE RIGHT FEMORAL VEIN AND MINIMAL RESIDUAL NONOCCLUSIVE THROMBUS WITHIN LEFT COMMON FEMORAL VEIN. A CT SCAN APPROX. 2½ YEARS AFTER FILTER PLACEMENT DEMONSTRATED 13° OF RIGHTWARD TILT AND INTERVAL DEVELOPMENT OF MULTIPLE GRADES OF INTERACTION WITH THE IVC WALL INCLUDING A GRADE 3 INTERACTION INVOLVING A PRIMARY FILTER LEG EXTENDING THROUGH THE WALL OF THE IVC AND ABUTTING THE WALL OF THE PROXIMAL RIGHT COMMON ILIAC ARTERY. ALTHOUGH THE FOOT APPEARS TO EXTEND INTO THE WALL OF THE ARTERY, IT DOES NOT APPEAR TO FULLY PENETRATE THE WALL AND EXTEND INTO THE LUMEN OF THE ARTERY. THERE ARE ALSO MULTIPLE GRADE 2 INTERACTIONS EXTENDING INTO THE PERICAVAL/RETROPERITONEAL FAT AND SIX SECONDARY LEGS DEMONSTRATED GRADE 1 INTERACTIONS. THE CALIBER OF THE IVC HAD CHANGED WHEN COMPARED TO THE PLACEMENT VENOGRAM. CT SCAN DEMONSTRATES THE LUMEN OF THE IVC, AT THE LEVEL OF THE IVC FILTER FEET, APPEAR SIGNIFICANTLY SMALLER AND IRREGULAR IN SIZE WHEN COMPARED TO THE PLACEMENT VENOGRAM. IN ADDITION, THERE IS INTERVAL DEVELOPMENT OF MULTIPLE PARA LUMBAR, RETROPERITONEAL AND BILATERAL PELVIC VENOUS COLLATERALS INDICATING THERE IS AN ELEMENT OF PHYSIOLOGIC OBSTRUCTION TO FLOW IN THIS SEGMENT OF THE IVC AND WITHIN THE ILIAC VEINS. ON THE INITIAL VENOGRAM, AT TIME OF IVC FILTER PLACEMENT, THESE WERE NOT PRESENT. THE DEVELOPMENT OF HIGH-GRADE IVC STENOSIS AND/OR FOCAL OCCLUSION, IS DIRECTLY RELATED TO THE IVC FILTER AND LIKELY THE EVOLUTION OF THROMBUS WITHIN THE IVC FILTER. HOWEVER, IT IS IMPOSSIBLE TO DETERMINE IF THE IVC FILTER CAUSED THE FOCAL THROMBOSIS OR IF THIS THROMBUS WAS DUE TO THE FILTER PERFORMING ITS INTENDED FUNCTION AND PREVENTED THE MIGRATION OF A POTENTIALLY FATAL THROMBUS FROM THE LOWER EXTREMITIES TO THE PULMONARY ARTERIES. THERE HAS ALSO BEEN INTERVAL WORSENING OF THE RIGHTWARD TILT AS WELL AS THE MULTIPLE GRADE 2 AND GRADE 3 INTERACTIONS WITH THE WALL OF THE IVC. THESE CHANGES MAY ALSO BE RELATED TO THE PRESUMED THROMBUS IN THE IVC FILTER THAT DURING THE RESORPTION/EVOLUTION OF THE THROMBUS THAT CAUSED THE IVC WALL TO CICATRIZE/SCAR AND NARROW WITH TIME, FACILITATED THE EXTENSION OF THE IVC FILTER LEGS THROUGH THE WALL. THE CAUSE OF PENETRATION IS INDETERMINATE, BUT IF THE FILTER IS NO LONGER CLINICALLY INDICATED, RETRIEVAL SHOULD STILL BE CONSIDERED TO HELP AVOID WORSENING PENETRATION OR OTHER FILTER RELATED COMPLICATIONS. THE COMPLAINT REPORT ALLEGES MIGRATION, TILT, VENA CAVA PERFORATION, ORGAN PERFORATION, PERFORATION TO MESENTERY, PERFORATION TO AORTA AND APEX ABUTS THE WALL OF THE IVC. THE SUBMITTED IMAGES DO DEMONSTRATE FILTER TILT, VENA CAVA PERFORATION AND THE APEX OF THE FILTER ABUTTING THE WALL O OF THE IVC, THE OTHER ALLEGATIONS ARE NOT CONFIRMED ON THE SUBMITTED IMAGES. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 Manufacturer Narrative · 0

ADDITIONAL INFORMATION: RELEVANT TESTS/LABORATORY DATA. EXEMPTION NUMBER: E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). PATIENT CODE: THROMBOSIS (2100)-LISTED IN THE IFU, OCCLUSION (1984)- NOT LISTED IN IFU. MFR SITE: 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 Manufacturer Narrative · 0

EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SINCE CATALOG# IS UNKNOWN 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS.