GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2019-00920
- Event Type
- Injury
- Date Received
- April 11, 2019
- Report Date
- August 1, 2019
- Manufacturer
- COOK INC
- Product Code
- DTK
- PMA / PMN Number
- K043509
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
UPON FURTHER REVIEW, IT WAS NOTED THE JAN2019 INVESTIGATION WAS CONDUCTED UNDER WCE. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC AND THIS COMPLAINT WAS TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC IN APR2019. THIS FOLLOW UP NUMBER 3 IS ISSUED TO CORRECT THE INVESTIGATION. INVESTIGATION/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. UNKNOWN IF THE REPORTED PHYSICAL & EMOTIONAL INJURIES, ANGUISH, STRESS, SHOCK, MENTAL SUFFERING ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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 INFORMATION: INVESTIGATION ¿ INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. UNKNOWN IF THE REPORTED PHYSICAL & EMOTIONAL INJURIES, ANGUISH, STRESS, SHOCK, MENTAL SUFFERING ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. (B)(4) DEVICES IN LOT. NO RELEVANT NOTES ON WO FOR DEVICE (IGTCFS-65-FEM) LOT# 2153345.NO OTHER COMPLAINTS ON LOT. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: PHYSICAL & EMOTIONAL INJURIES, ANGUISH, STRESS, SHOCK, MENTAL SUFFERING. 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 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.
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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2008 VIA THE RIGHT COMMON FEMORAL VEIN AS PROPHYLACTIC POST POLY TRAUMA. PATIENT ALLEGES VENA CAVA PERFORATION. PATIENT FURTHER ALLEGES TO HAVE EXPERIENCED, "PERFORATION, SEVERE PHYSICAL INJURIES AND EMOTIONAL INJURIES INCLUDING ANGUISH, STRESS, SHOCK AND MENTAL SUFFERING AS A RESULT OF THE IVC FILTER."
THE PREVIOUS MDR WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER MANUFACTURER REPORT REFERENCE# 3002808486-2019-00096. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL REPORT, COOK INC INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER MANUFACTURER REPORT REFERENCE# 1820334-2019-00919. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER DEVICE ON (B)(6) 2008. 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 |
|---|---|---|---|---|---|---|---|
| 299904 | GUNTHER TULIP FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | 2153345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |