UNKNOWN
Report
- Report Number
- 3002808486-2016-01277
- Event Type
- Injury
- Date Received
- October 26, 2016
- Date of Event
- October 13, 2016
- Report Date
- October 13, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374 OR K090140. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374 OR K090140. (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 K061815, K073374 OR K090140. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: POST-DEPLOYMENT FLUOROSCOPY DEMONSTRATED GRADE 1 INTERACTIONS WITH THE WALL OF THE IVC AND ALL OF THE CELECT FILTER'S PRIMARY AND SECONDARY LEGS, BUT WITH NO EVIDENCE OF PERFORATION OR PERICAVAL INFLAMMATORY CHANGES. HOWEVER, FIVE YEARS LATER TWO PRIMARY FILTER LEGS DEMONSTRATED GRADE 3 INTERACTIONS EXTENDING INTO THE LUMEN OF DUODENUM AND TWO ADDITIONAL PRIMARY FILTER LEGS CONTINUED TO EXTEND INTO THE RETROPERITONEAL FAT WITHOUT EVIDENCE OF PERICAVAL INFLAMMATORY CHANGES. THE FILTER WAS REMOVED BY ADVANCED TECHNIQUE. 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 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 INITIAL REPORTER: A CELECT FILTER WAS RETRIEVED FROM 2011 PLACEMENT. THE FILTER WAS INTERACTING WITH DUODENUM. PATIENT OUTCOME: UNKNOWN.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A CELECT FILTER WAS RETRIEVED FROM 2011 PLACEMENT. THE FILTER WAS INTERACTING WITH DUODENUM. ADDITIONAL INFORMATION RECEIVED 26OCT2016: FILTER PLACED ON (B)(6) 2011, FIRST CT SHOWS FILTER FINE. THEN ON (B)(6) 2015 SHOWS PERFORATION BUT NO SYMPTOMS. THEN RECENTLY PATIENT HAD SCOPING PROCEDURE DUE TO ABDOMINAL PAIN, WHERE LEG WAS FOUND. FIRST TRIED RETRIEVING WITH GTRS BUT COULDN'T GRASP HOOK SO USED LOOP SNARE TECHNIQUE THROUGH 16F REINFORCED PERFORMER SHEATH. SUCCESSFULLY RETRIEVED FILTER. PATIENT OUTCOME: PATIENT FINE POST PROCEDURE. ADDITIONAL INFORMATION RECEIVED 26OCT2016: ABDOMINAL PAIN. SUCCESSFULLY RETRIEVED FILTER AND PATIENT FINE POST PROCEDURE.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A CELECT FILTER WAS RETRIEVED FROM 2011 PLACEMENT. THE FILTER WAS INTERACTING WITH DUODENUM. ADDITIONAL INFORMATION RECEIVED 26OCT2016: FILTER PLACED ON (B)(6) 2011, FIRST CT SHOWS FILTER FINE. THEN ON (B)(6) 2015 SHOWS PERFORATION BUT NO SYMPTOMS. THEN RECENTLY PATIENT HAD SCOPING PROCEDURE DUE TO ABDOMINAL PAIN, WHERE LEG WAS FOUND. FIRST TRIED RETRIEVING WITH GTRS BUT COULDN'T GRASP HOOK SO USED LOOP SNARE TECHNIQUE THROUGH 16F REINFORCED PERFORMER SHEATH. SUCCESSFULLY RETRIEVED FILTER. PATIENT OUTCOME: PATIENT FINE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710203 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |