GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2017-02808
- Event Type
- Malfunction
- Date Received
- August 31, 2017
- Report Date
- October 24, 2017
- Manufacturer
- COOK INC
- Product Code
- DTK
- PMA / PMN Number
- K072240
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
CORRECTION: THE FOLLOWING FIELDS WERE UPDATED. PRODUCT PROBLEM TO ADVERSE EVENT AND PRODUCT PROBLEM, OUTCOMES ATTRIBUTED TO ADVERSE EVENT: STOMACH PAIN AND DEPRESSION, RELEVANT TESTS/LABORATORY DATA: CT SCAN, MEDICATIONS. (B)(4). PMA/510K: K02426 TO K072240. 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 'TULIP, VC PERFORATION, PE, PAIN, NAUSEA, ANXIETY'. 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. PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS REPORTED THAT THE PULMONARY EMBOLISM IN SOME CASES MAY ORIGINATE FROM UPPER EXTREMITIES INSTEAD OF LOWER EXTREMITY VEINS. WITH ALL FILTERS, THERE IS SOME RISK OF FURTHER PULMONARY EMBOLISM. UNKNOWN IF THE REPORTED PAIN, NAUSEA, ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. NO RELEVANT NOTES FOUND IN DEVICE WORK ORDER. NO OTHER COMPLAINTS FOUND IN DEVICE LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL. 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.
(B)(4). 510(K) K032426. CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT PROBLEM, SERIOUS INJURY TO MALFUNCTION. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2006. IT IS ALLEGED THAT THE PLAINTIFF WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
PATIENT IS ALLEGING STOMACH PAIN AND DEPRESSION.
THIS ADDITIONAL INFORMATION RECEIVED ON 09/15/2017 AS FOLLOWS: PATIENT RECEIVED AN IMPLANT ON (B)(6) 2006 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO HISTORY OF RECURRENT PULMONARY EMBOLISM. PATIENT EXPERIENCED VENA CAVA PERFORATION; PATIENT IS ALLEGING PULMONARY EMBOLISM, PAIN, NAUSEA, ANXIETY. DEVICE SUCCESSFUL RETRIEVED ON (B)(6) 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615041 | GUNTHER TULIP JUGULAR VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |