GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2020-00428
- Event Type
- Injury
- Date Received
- February 24, 2020
- Report Date
- February 24, 2020
- Manufacturer
- COOK INC
- Product Code
- DTK
- UDI-DI
- 10827002330167
- PMA / PMN Number
- K043509
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED BY WILLIAM COOK (B)(4) UNDER MANUFACTURER REPORT REFERENCE# 3002808486-2020-00035. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL MEDWATCH REPORT, COOK INC. INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER THE MANUFACTURER REPORT REFERENCE #. REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. (B)(4). INVESTIGATION: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA PERFORATION, DEEP VEIN THROMBUS, MIGRATION, TILT, LIMITED MOBILITY, MEDICAL MISDIAGNOSIS. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. 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 OR FILTER FRAGMENT MIGRATION AND (OR) EMBOLIZATION (E.G., MOVEMENT TO THE HEART OR LUNGS) HAS BEEN REPORTED. FILTER OR FILTER FRAGMENT MOVEMENT HAS OCCURRED IN BOTH THE CRANIAL AND CAUDAL DIRECTION AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS SMALLER OR LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; DEPLOYMENT INTO THROMBUS; DISLODGEMENT DUE TO LARGE THROMBUS BURDENS; 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: FILTER MIGRATION, TRAUMA TO ADJACENT STRUCTURES. 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 LIMITED MOBILITY, MEDICAL MISDIAGNOSIS ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 20 DEVICES IN LOT. NO RELEVANT NOTES ON WORK ORDER. THE 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. 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.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 DUE TO PRIOR BLOOD CLOTS. PATIENT IS ALLEGING MIGRATION, TILT, AND VENA CAVA PERFORATION. THE PATIENT FURTHER ALLEGES MISDIAGNOSIS AS CARDIAC OR GERD, LIMITED MOBILITY TO RUN/TENNIS/GOLF/SKIING, DEEP VEIN THROMBOSIS (DVT). SUCCESSFUL VASCULAR RETRIEVAL ON (B)(6) 2018 DUE TO PERFORATED VENA CAVA, MIGRATED AND CAUSED CONSTANT PAIN. 13JUN2018, PER A REPORT FROM COMPUTED TOMOGRAPHY (CT); ¿FINDINGS: THE 1ST IMAGE SHOWS AN EXPANDED INFERIOR VENA CAVA FILTER LEVEL OF L2-L3. A WIRE IS SEEN PASSED TO THAT LEVEL. THE 2ND IMAGE SHOWS CONTRAST INJECTION OUTLINING A NORMAL CALIBER INFERIOR VENA CAVA. THE 2ND IMAGE SHOWS COLLAPSE OF THE CAVA FILTER. THIRD IMAGE SHOWS AN OPACIFIED INFERIOR VENA CAVA WITH EXPANDED FILTER. THE FINAL IMAGE SHOWS A RETRIEVAL CATHETER APPARENTLY PASSED FROM THE JUGULAR REGION TO THE SUPERIOR MARGIN OF VENA CAVA FILTER. IMPRESSION: IMAGE GUIDANCE FOR INFERIOR VENA CAVA FILTER REMOVAL PROCEDURE.¿ 13JUN2018, PER A REPORT FROM RETRIEVAL REPORT (SUCCESSFUL); ¿FINDINGS: 1. SUCCESSFUL RETRIEVAL OF IVC FILTER IN ITS ENTIRETY. 2. NO EVIDENCE OF IVC INJURY.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210233 | GUNTHER TULIP FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | G33016 | 2741491 | 10827002330167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| O |