GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2016-01006
- Event Type
- Malfunction
- Date Received
- September 7, 2016
- Date of Event
- January 6, 2014
- Report Date
- April 24, 2019
- Manufacturer
- COOK INC
- Product Code
- DTK
- PMA / PMN Number
- K043509
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
(B)(4). EVALUATION: NO INFORMATION REGARDING THE EVENT. THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. UNABLE TO COMMENT ON THE ALLEGED INJURY. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.
THIS FILE WAS PREVIOUSLY REPORTED AS MANUFACTURER CHANGE UNDER 3002808486-2015-00051 BY WILLIAM COOK EUROPE. ADDITIONAL INFORMATION PROVIDED CONFIRMED THIS REPORT SHOULD BE KEPT BY COOK INC. THIS FILE WAS SENT BACK TO COOK INC. AS THE APPROPRIATE MANUFACTURER FOR CORRECT REPORTING. ALL AVAILABLE INFORMATION WAS REPORTED. NO FURTHER DETAILS HAVE BEEN PROVIDED.
ADDITIONAL INFORMATION INVESTIGATION - IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE.
ADDITIONAL INFORMATION: THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. .
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 "VC PERFORATION, MIGRATION" 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. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. THE LOT NUMBER IS UNKNOWN. NO RELEVANT NOTES ON NEITHER DEVICE; 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.
ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY WILLIAM COOK EUROPE. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, COOK INC. INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM COOK INC. TO WILLIAM COOK EUROPE.
IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2006 AT AN UNNAMED HOSPITAL IN (B)(6).' IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2006 AT AN UNNAMED HOSPITAL IN (B)(6).' IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
AS REPORTED PER CT REPORT DATED 02FEB2012, INFRARENAL INFERIOR VENA CAVA (IVC) IDENTIFIED. QUESTION OF THE INFERIOR PRONGS WHICH APPEARED TO BE OUTSIDE OF THE INFERIOR VENA CAVA LUMEN VERSUS ARTIFACT. INFERIOR VENA CAVA FILTER IS CLEARLY MIGRATED.
NO ADDITIONAL INFORMATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584638 | GUNTHER TULIP FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Life Threatening| O |