BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6131225 · Received November 29, 2016

    Report

    Report Number
    3002808486-2016-01450
    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

    Additional Manufacturer Narrative · 1

    (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. DEVICE MANUFACTURE DATE: UNKNOWN AS LOT# IS UNKNOWN. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (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: A REVIEW OF A CT SCAN FOUND ALL 4 PRIMARY CELECT FILTER LEGS DEMONSTRATING GRADE 3 INTERACTIONS WITH THE IVC WALL; ONE LEG EXTENDING IN THE LUMEN OF DUODENUM, ONE LEG EXTENDING INTO LUMEN OF AORTA, ONE LEG ABUTTING THE VERTEBRAL BODY, AND ONE LEG ABUTTING THE WALL OF DUODENUM. THE VISUALIZED SECONDARY LEGS ALL DEMONSTRATE GRADE 1 INTERACTIONS WITH IVC WALL. THE PATIENT PRESENTED WITH RIGHT FLANK PAIN AND NAUSEA AND VOMITING WITH A DWELL TIME OF 1½ YEAR AND THE FILTER WAS SUCCESSFULLY RETRIEVED UTILIZING ADVANCED TECHNIQUES. FOLLOWING REMOVAL THE PATIENT'S SYMPTOMS HAD RESOLVED. THE FILTER WAS PLACED AFTER POLYTRAUMA DUE TO HIGH RISK OF VENOUS THROMBOEMBOLIC DISEASE, BUT BASED ON LIMITED INFORMATION PROVIDED THE EXACT REASON FOR THE PRIMARY FILTER LEG PERFORATIONS CANNOT BE DETERMINED. 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 or Problem · 1

    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; RIGHT FLANK PAIN NAUSEA AND VOMITING. PENETRATION BY THE FILTER TINES OF L2, AORTA, AND DUODENUM. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. POSTRETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVAL HEMATOMA, AND CAVAL THROMBUS. RESOLUTION OF ABDOMINAL PAIN 1 WEEK POSTOPERATIVELY. PT LOST TO LONG-TERM FOLLOW-UP." PATIENT OUTCOME: NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. ADDITIONAL PROCEDURES REQUIRED: ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. ADVERSE EVENTS REPORTED: ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY.

    Description of Event or Problem · 1

    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; RIGHT FLANK PAIN NAUSEA AND VOMITING. PENETRATION BY THE FILTER TINES OF L2, AORTA, AND DUODENUM. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. POSTRETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVAL HEMATOMA, AND CAVAL THROMBUS. RESOLUTION OF ABDOMINAL PAIN 1 WEEK POSTOPERATIVELY. PT LOST TO LONG-TERM FOLLOW-UP." PATIENT OUTCOME: NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. ADDITIONAL PROCEDURES REQUIRED: ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY. ADVERSE EVENTS REPORTED: ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN, FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783093 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R