UNKNOWN
Report
- Report Number
- 3002808486-2016-01448
- Event Type
- Injury
- Date Received
- November 29, 2016
- Report Date
- November 10, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). CATALOG #: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT # IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K090140, K112119, K121057 OR K121629. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K090140, K112119, K121057 OR K121629. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AN IMAGE REVIEW FOUND A PRIMARY LEG OF AN INFRARENAL CELECT FILTER WITH A 2 YEAR DWELL TIME DEMONSTRATING A GRADE 3 INTERACTION WITH THE IVC WALL AND IS SEEN EXTENDING THROUGH THE POSTERIOR WALL OF DUODENUM AND APPEARS TO EXTEND INTO THE LUMEN OF DUODENUM. THE REMAINING PRIMARY AND SECONDARY LEGS APPEAR TO BE CONTAINED WITHIN THE WALL OF IVC. THE REPORTED INTERACTION OF AORTA AND VERTEBRAL BODIES CANNOT BE CONFIRMED, BUT MAY HAVE BEEN PRESENT ON OTHER PORTIONS OF THE CT. THE REPORTED ACUTE SEPSIS MAY BE RELATED TO THE DUODENAL PERFORATION. FILTER WAS PLACED DUE TO AN INDICATION OF ACUTE DVT AND PE AND THE EXACT REASON FOR THE FILTER LEG PERFORATION CANNOT BE DETERMINED. IT IS NOTED THAT FOLLOWING FILTER RETRIEVAL UTILIZING ADVANCED TECHNIQUES THERE WAS "RESOLUTION OF SEPSIS AND ABDOMINAL PAIN. SIX (6) YEARS-FOLLOW-UP: IMPROVEMENT IN ABDOMINAL PAIN." 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. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. 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 MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO JOURNAL ARTICLE "ENDOVASCULAR MANAGEMENT OF SYMPTOMATIC GASTROINTESTINAL COMPLICATIONS ASSOCIATED WITH RETRIEVABLE INFERIOR VENA CAVA FILTERS" BY GENOVESE ET AL: "SYMPTOMATIC GASTROINTESTINAL COMPLICATION; LEFT UPPER QUADRANT PAIN, FATIGUE, MYALGIAS, FEVER, SEPSIS (ENTERIC FLORA BACTEREMIA, HYPOTENSION, AND TACHYCARDIA). FOUR TINES BEYOND THE WALL OF THE IVC; PENETRATION OF THE DUODENUM, AORTA, VERTEBRA. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. COMPLETION VENOGRAM AND AORTOGRAM. POST-RETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVAL HEMATOMA, AND CAVAL THROMBUS. RESUMED ANTICOAGULATION. RESOLUTION OF SEPSIS AND ABDOMINAL PAIN. SIX YEAR-FOLLOW-UP: IMPROVEMENT IN ABDOMINAL PAIN, TOLERATING ORAL INTAKE, NO LONG-TERM DVT/PE, NO LONG-TERM COMPLICATIONS, NO LONG-TERM ANTICOAGULATION." PATIENT OUTCOME: NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. ADDITIONAL PROCEDURES REQUIRED: ACUTE SEPSIS WAS IMMEDIATELY TREATED WITH BROAD-SPECTRUM ANTIBIOTICS AND UNDERWENT ENDOVASCULAR RETRIEVAL ONCE HE STABILIZED. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. COMPLETION VENOGRAM AND AORTOGRAM. ADVERSE EVENTS REPORTED: SYMPTOMATIC GASTROINTESTINAL COMPLICATION; LEFT UPPER QUADRANT PAIN, FATIGUE, MYALGIAS, FEVER, SEPSIS (ENTERIC FLORA BACTEREMIA, HYPOTENSION, AND TACHYCARDIA).
DESCRIPTION OF EVENT ACCORDING TO JOURNAL ARTICLE "ENDOVASCULAR MANAGEMENT OF SYMPTOMATIC GASTROINTESTINAL COMPLICATIONS ASSOCIATED WITH RETRIEVABLE INFERIOR VENA CAVA FILTERS" BY GENOVESE ET AL: "SYMPTOMATIC GASTROINTESTINAL COMPLICATION; LEFT UPPER QUADRANT PAIN, FATIGUE, MYALGIAS, FEVER, SEPSIS (ENTERIC FLORA BACTEREMIA, HYPOTENSION, AND TACHYCARDIA). FOUR TINES BEYOND THE WALL OF THE IVC; PENETRATION OF THE DUODENUM, AORTA, VERTEBRA. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. COMPLETION VENOGRAM AND AORTOGRAM. POST-RETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVAL HEMATOMA, AND CAVAL THROMBUS. RESUMED ANTICOAGULATION. RESOLUTION OF SEPSIS AND ABDOMINAL PAIN. 6 YEARS-FOLLOW-UP: IMPROVEMENT IN ABDOMINAL PAIN, TOLERATING ORAL INTAKE, NO LONG-TERM DVT/PE, NO LONG-TERM COMPLICATIONS, NO LONG-TERM ANTICOAGULATION." PATIENT OUTCOME: NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. ADDITIONAL PROCEDURES REQUIRED: ACUTE SEPSIS WAS IMMEDIATELY TREATED WITH BROAD-SPECTRUM ANTIBIOTICS AND UNDERWENT ENDOVASCULAR RETRIEVAL ONCE HE STABILIZED. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. COMPLETION VENOGRAM AND AORTOGRAM. ADVERSE EVENTS REPORTED: SYMPTOMATIC GASTROINTESTINAL COMPLICATION; LEFT UPPER QUADRANT PAIN, FATIGUE, MYALGIAS, FEVER, SEPSIS (ENTERIC FLORA BACTEREMIA, HYPOTENSION, AND TACHYCARDIA).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 781858 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Life Threatening| R |