UNKNOWN
Report
- Report Number
- 3002808486-2021-00025
- Event Type
- Injury
- Date Received
- January 18, 2021
- Report Date
- February 19, 2021
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC. 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 PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC.
MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER THIS COULD BE WRONG AS THE FIRST SALE OF COOK CELECT FILTER WAS (B)(6) 2007. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. SUMMARY OF INVESTIGATIONAL FINDINGS: 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. 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "ON OR ABOUT (B)(6) 2006, [PT] WAS IMPLANTED WITH A COOK CELECT FILTER. [PT] HAS SUFFERED SERIOUS INJURY AS A RESULT OF THE IMPLANTATION OF THE COOK CELECT FILTER. SPECIFICALLY, [PT] SUFFERED PERFORATION OF HER IVC BY FOUR (4) PRONGS OF HER COOK CELECT IVC FILTER, WITH A MAXIMUM DISTANCE OF 4.82 MILLIMETERS (MM)." IT IS ALLEGED THAT "[PT] IS AT RISK FOR FUTURE PROGRESSIVE PERFORATIONS BY THE CELECT FILTER WHICH COULD FURTHER INJURE ADJACENT ORGANS, BLOOD VESSELS, AND STRUCTURES, AS WELL AS FRACTURING OF THE IVC FILTER AND MIGRATION OF THE CELECT FILTER OR PIECES THEREOF. [PT] FACES NUMEROUS HEALTH RISKS, INCLUDING THE RISK OF DEATH. [PT] WILL REQUIRE ONGOING MEDICAL CARE AND MONITORING FOR THE REST OF HER LIFE. IT IS UNKNOWN IF THE FILTER CAN BE RETRIEVED BY ANY MEANS OTHER THAN AN OPEN SURGICAL PROCEDURE". IT IS FURTHER ALLEGED THAT "[PT] HAS PAIN AND SUFFERING AND MENTAL ANGUISH IN THE PAST AND WHICH, IN REASONABLE PROBABILITY, WILL SUSTAIN IN THE FUTURE". HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80326 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |