COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2016-00453
- Event Type
- Malfunction
- Date Received
- June 8, 2016
- Report Date
- May 28, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K090140
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- ATTORNEY
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). ACCORDING TO DEVICE HISTORY RECORDS, BASED ON THE LOT NUMBER PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS OR THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G., THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA IN THE SITUATIONS DESCRIBED IN THE IFU. 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 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 TOUCHING A NERVE, STRESS/PSYCHOLOGICAL ISSUES, CONSTANT PAIN AND WORRY ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: TOUCHING A NERVE, STRESS/PSYCHOLOGICAL ISSUES, CONSTANT PAIN AND WORRY. 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.
(B)(4). 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. EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113.
NO NEW INFORMATION TO REPORT AT THIS TIME.
PATIENT RECEIVED AN IMPLANT VIA THE RIGHT COMMON FEMORAL VEIN. IN ADDITION, PATIENT ALLEGES [FILTER IS] TOUCHING A NERVE. PATIENT FURTHER ALLEGES TO HAVE EXPERIENCED STRESS AND PSYCHOLOGICAL ISSUES.
(B)(4). LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS EITHER GUNTHER TULIP MREYE, GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER, OR COOK CELECT PLATINUM. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855, K032426, K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REFERENCE #(B)(4). EXEMPTION NUMBER E2016032. (B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT PROBLEM SERIOUS INJURY TO MALFUNCTION EC METHOD CODES UPDATED. 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 "PATIENT IS CLAIMING CONTINUOUS PAIN, HARD TO WALK AND LIFT, AND HIGH STRESS/MARITAL ISSUES. FILTER HAS MADE PATIENT WORRIED AND CONCERNED THAT HE WILL EXPERIENCE INJURY OR DEATH." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. A REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE: IN POTENTIAL ADVERSE EVENTS ARE MENTIONED: ¿ DAMAGE TO THE VENA CAVA; ¿ PULMONARY EMBOLISM; ¿ FILTER EMBOLIZATION; ¿ VENA CAVA PERFORATION; ¿ VENA CAVA OCCLUSION OR THROMBOSIS; ¿ HEMATOMA AT VASCULAR ACCESS SITE; ¿ HEMORRHAGE; ¿ INFECTION AT VASCULAR ACCESS SITE; ¿ DEATH. 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. MANUFACTURER REFERENCE #(B)(4). EXEMPTION NUMBER E2016032. (B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT PROBLEM. SERIOUS INJURY TO MALFUNCTION. EC METHOD CODES UPDATED. 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 "PATIENT IS CLAIMING CONTINUOUS PAIN, HARD TO WALK AND LIFT, AND HIGH STRESS/MARITAL ISSUES. FILTER HAS MADE PATIENT WORRIED AND CONCERNED THAT HE WILL EXPERIENCE INJURY OR DEATH." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. A REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE: IN POTENTIAL ADVERSE EVENTS ARE MENTIONED: ¿ DAMAGE TO THE VENA CAVA; ¿ PULMONARY EMBOLISM; ¿ FILTER EMBOLIZATION; ¿ VENA CAVA PERFORATION; ¿ VENA CAVA OCCLUSION OR THROMBOSIS; ¿ HEMATOMA AT VASCULAR ACCESS SITE; ¿ HEMORRHAGE; ¿ INFECTION AT VASCULAR ACCESS SITE; ¿ DEATH. 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.
MANUFACTURER REF# (B)(4). LOT#: IGTCFS-65-1-UNI-CELECT. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK FILTER." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK FILTER." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
ADDITIONAL INFORMATION RECEIVED 2/14/2017 - PATIENT ALLEGES IVC FILTER IMPLANTED ON (B)(6) 2010. FILTER IMPLANTED FOR THE PREVENTION OF DVT (WHICH IS A PRE-EXISTING CONDITION). NO ATTEMPTS TO REMOVE FILTER. PATIENT IS ALLEGING CONTINUOUS PAIN, HARD TO WALK AND LIFT, AND HIGH STRESS/MARITAL ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360732 | COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |