BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6131230 · Received November 29, 2016

    Report

    Report Number
    3002808486-2016-01452
    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. G5) SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. PMA 510(K): SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K090140, K112119, K121057 OR K121629. MFG DATE: UNKNOWN AS LOT# IS UNKNOWN. (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; LOWER BACK PAIN AND RIGHT LOWER EXTREMITY WEAKNESS, ABDOMINAL PAIN WITH ANOREXIA. PENETRATION BY THE FILTER TINES INTO L3 AND DUODENUM." IT IS NOTED THAT AFTER ENDOVASCULAR FILTER RETRIEVAL THE PATIENT EXPERIENCED RESOLUTION OF ABDOMINAL PAIN AND IMPROVEMENT IN BACK 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. 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; LOWER BACK PAIN AND RIGHT LOWER EXTREMITY WEAKNESS, ABDOMINAL PAIN WITH ANOREXIA. PENETRATION BY THE FILTER TINES INTO L3 AND DUODENUM. ENDOVASCULAR RETRIEVAL OF IVC FILTER ACCESS: R IJ, R FEMORAL VEIN. POST RETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVAL HEMATOMA, AND CAVAL THROMBUS. RESOLUTION OF ABDOMINAL PAIN, IMPROVEMENT IN BACK PAIN. 2 MONTHS FOLLOW-UP: NO ABDOMINAL PAIN, IMPROVED ORAL INTAKE, IMPROVED BACK PAIN, RESOLVED RIGHT LOWER EXTREMITY WEAKNESS. DUPLEX ULTRASOUND SCAN NEGATIVE FOR CAVAL THROMBUS OR LOWER EXTREMITY DVT." 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: SYMPTOMATIC GASTROINTESTINAL COMPLICATION; LOWER BACK PAIN AND RIGHT LOWER EXTREMITY WEAKNESS, ABDOMINAL PAIN WITH ANOREXIA. RADICULOPATHY ASSOCIATED WITH TINE EROSION INTO L3.

    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; LOWER BACK PAIN AND RIGHT LOWER EXTREMITY WEAKNESS, ABDOMINAL PAIN WITH ANOREXIA. PENETRATION BY THE FILTER TINES INTO L3 AND DUODENUM. ENDOVASCULAR RETRIEVAL OF IVC FILTER ACCESS: R IJ, R FEMORAL VEIN. POST-RETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVAL HEMATOMA, AND CAVAL THROMBUS. RESOLUTION OF ABDOMINAL PAIN, IMPROVEMENT IN BACK PAIN. 2 MONTHS FOLLOW-UP: NO ABDOMINAL PAIN, IMPROVED ORAL INTAKE, IMPROVED BACK PAIN, RESOLVED RIGHT LOWER EXTREMITY WEAKNESS. DUPLEX ULTRASOUND SCAN NEGATIVE FOR CAVAL THROMBUS OR LOWER EXTREMITY DVT." 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: SYMPTOMATIC GASTROINTESTINAL COMPLICATION; LOWER BACK PAIN AND RIGHT LOWER EXTREMITY WEAKNESS, ABDOMINAL PAIN WITH ANOREXIA. RADICULOPATHY ASSOCIATED WITH TINE EROSION INTO L3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783203 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R