UNKNOWN
Report
- Report Number
- 3002808486-2016-01451
- 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. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K090140, K112119, K121057 OR K121629. (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: NO IMAGING WAS PROVIDED AND THEREFORE IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE OCCURRED BASED ON THE LIMITED INFORMATION MADE AVAILABLE TO US IN THE ARTICLE CONCERNING "SYMPTOMATIC GASTROINTESTINAL COMPLICATION; MILD ABDOMINAL PAIN. PENETRATION BY THE FILTER TINES OF L3, DUODENUM, AND AORTA. ENDOVASCULAR RETRIEVAL OF IVC FILTER." 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. 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; MILD ABDOMINAL PAIN. PENETRATION BY THE FILTER TINES OF L3, DUODENUM, AND AORTA. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY COMPLETION VENOGRAM AND AORTOGRAM." PATIENT OUTCOME: NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. ADDITIONAL PROCEDURES REQUIRED: ENDOVASCULAR RETRIEVAL OF IVC FILTER ADVERSE EVENTS REPORTED: SYMPTOMATIC GASTROINTESTINAL COMPLICATION AND MILD ABDOMINAL PAIN.
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; MILD ABDOMINAL PAIN. PENETRATION BY THE FILTER TINES OF L3, DUODENUM, AND AORTA. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY COMPLETION VENOGRAM AND AORTOGRAM." PATIENT OUTCOME: NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. ADDITIONAL PROCEDURES REQUIRED: ENDOVASCULAR RETRIEVAL OF IVC FILTER ADVERSE EVENTS REPORTED: SYMPTOMATIC GASTROINTESTINAL COMPLICATION AND MILD ABDOMINAL PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783006 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Life Threatening| R |