UNKNOWN
Report
- Report Number
- 1820334-2019-02576
- Event Type
- Injury
- Date Received
- October 11, 2019
- Report Date
- May 10, 2023
- Manufacturer
- COOK INC
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: A2, A4, B2, B5, B6, B7, H6. H6 DEVICE CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (3191) WAS SELECTED FOR THE ALLEGED DEVICE TILT. H6 DEVICE CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (3191) WAS SELECTED FOR THE ALLEGED PERFORATION. INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: (PULMONARY EMBOLISM) PE, VENA CAVA (VC) PERFORATION, DEEP VEIN THROMBOSIS (DVT), EMBEDMENT, TILT, STOMACH PAIN, GENERALIZED PAIN, AND STRESS. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. NEW PE AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: PULMONARY EMBOLISM. 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. IVC OCCLUSION/ THROMBOSIS, NEW DVT, IVC STENOSIS AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VENA CAVA OCCLUSION OR THROMBOSIS, VENA CAVA STENOSIS, DEEP VEIN THROMBOSIS. 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. UNKNOWN IF THE REPORTED STOMACH PAIN, GENERALIZED PAIN, AND STRESS ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. CATALOG AND LOT NUMBERS ARE UNKNOWN, HOWEVER, 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES 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.
INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. PER QUALITY ENGINEERING REVIEW, THE ADDITIONAL INFORMATION PROVIDED FOR THIS COMPLAINT DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION. THEREFORE, NO NEW INVESTIGATION ACTIVITIES WILL BE CONDUCTED AT THIS TIME. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. CATALOG AND LOT NUMBER ARE UNKNOWN, HOWEVER, THE ALLEGED TULIP 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2006 VIA RIGHT INTERNAL JUGULAR VEIN DUE TO POST DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, DVT, POST-THROMBOTIC SYNDROME AND EMBEDMENT. THE PATIENT FURTHER ALLEGES ¿STOMACH PAIN, GENERALIZED PAIN, VERY STRESSED SINCE I REALIZED WHAT HAPPENED TO THE FILTER IMPLANTED IN ME.¿ THE PATIENT FURTHER WRITES AS FOLLOWS: ¿PULMONARY EMBOLISMS TWO TIMES AFTER THIS IVC FILTER. I AM ON BLOOD THINNER INJECTION 2 TIMES A DAY FOR THE REST OF MY WHAT LIFE I HAVE LEFT. I WAS TOLD THERE IS NOTHING ELSE THAT CAN BE DONE FOR ME, BESIDE TAKEN THE INJECTIONS TWICE A DAY. I WAS TOLD BY DR. (NAME REMOVED) AT (FACILITY NAME REMOVED) THAT I WILL EVENTUALLY DIE WHEN THE BLOOD CLOTS REROUTE THEMSELVES TO MY HEART. I AM SLEEPLESS AT NIGHT HOPING I AWAKEN EACH MORNING. I HAVE BEEN PREPARING MY DAUGHTER AGE 9 HOW TO LIVE WITHOUT MOMMY. I AM SO AFRAID TO LEAVE HER. SHE IS NOT A STRONG MINDED KID LIKE I WAS. (NAME REMOVED) IS VERY TIMIDET AND GETS BULLIED BECAUSE SHE WEARS GLASSES. LATE DR. (NAME REMOVED) TOLD ME I MAY NOT LIVE TO SEE 50 YEARS OLD AND THAT IN TWO YEARS. DR. (NAME REMOVED) AT (FACILITY NAME REMOVED) WOULD TELL ME I WAS A WALKING AMBULANCE AND DIDN¿T KNOW I WAS STILL ALIVE. I NEVER KNEW WHEN DR. (NAME REMOVED) SAID I COULD NOT HAVE KIDS ANYMORE, I WAS NOT TO GET PG [SIC]. I LIVE WITH TWO LEGS SO DISCOLORED I CAN¿T WEAR DRESSES THAT SHOW MY LEGS. MY LEGS BURN ALWAYS AND STAY SWOLLEN. IT¿S LIKE LIGHTING STROKE AND NEEDLE PINCHES. MY STOMACH IS VERY DISCOLORED AND PAINFUL FROM INJECTIONS 2 TIMES A DAY. MY LITTLE GIRL IS FRIGHTEN BY THE SITE OF MY NEEDLE SHE RUNS OUT THE ROOM. I AM THINK MY MEMORY IS GOING AWAY SHORT TERM BECAUSE MY LITTLE GIRLY IS MY LIFE SAVER SHE REMINDS ME TO TAKE MY INJECTIONS. (CHILD NAME) TOLD ME THAT GOD SENT HER TO ME TO TAKE CARE OF ME. I TRULY BELIEVE HER BECAUSE MY FAMILY WAS TIRED OF HELPING ME. MY SCARIEST NIGHT ARE WHEN I CANNOT BREATH NORMAL IT MAKES ME CRY WHICH DON¿T HELP MY BREATHING EIGHTER. I DO NOT REALLY LIKE TO TALK ABOUT MY HEALTH BECAUSE IT MAKES ME MORE DEPRESSED & I STAYED IN THE HOUSE FOR DAYS.¿ PER A VENOUS DUPLEX ULTRASOUND OF THE BILATERAL LOWER EXTREMITIES, DATED (B)(6) 2006, ¿BILATERAL LOWER EXTREMITY DEEP VENOUS THROMBOSIS.¿ PER A CT (COMPUTED TOMOGRAPHY) SCAN OF THE ABDOMEN AND PELVIS DATED (B)(6) 2017, ¿SOME OF THE FILTER STRUTS HAVE PENETRATED THROUGH THE WALL OF THE IVC INTO THE PERICAVAL/MESENTERIC FAT. THE FILTER IS TILTED ANTERIORLY WITH ITS PROXIMAL CONE LYING ON THE WALL OF THE IVC POSSIBLY EMBEDDED IN IT.¿
PER COMPUTED TOMOGRAPHY REPORT, "FILTER POSITION: BELOW THE RENAL VEINS." "FILTER TILT: YES, SEE IMPRESSIONS." "FILTER PENETRATION: YES, SEE IMPRESSIONS." "IMPRESSIONS: SOME OF THE FILTER STRUTS HAVE PENETRATED THROUGH THE WALL OF THE IVC INTO THE PERICAVAL/MESENTERIC FAT. SEE AXIAL IMAGE 110/224. THE FILTER IS TILTED ANTERIORLY WITH ITS PROXIMAL CONE LYING ON THE WALL OF THE IVC POSSIBLY EMBEDDED IN IT. SEE SAGITTAL IMAGE 44." "ADDENDUM: COOK GUNTHER TULIP FILTER. THE ANTERIOR STRUT PENETRATES 12 MM THROUGH THE IVC WALL. SAGITTAL IMAGE 45. THE LEFT STRUT PENETRATES 8 MM THROUGH THE IVC WALL. CORONAL IMAGE 50. THE POSTERIOR STRUT PENETRATES 2.2 MM THROUGH THE IVC WALL. SAGITTAL IMAGE 42. THE RIGHT STRUT PENETRATES 9 MM THROUGH THE IVC WALL. CORONAL IMAGE 48."
OCCUPATION: NON-HEALTHCARE PROFESSIONAL. CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN; HOWEVER, 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. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION AND/OR NO DEVICE FAILURE PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP IVC FILTER DEVICE ON (B)(6) 2006. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 974470 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Life Threatening| O |