BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6131224 · Received November 29, 2016

    Report

    Report Number
    3002808486-2016-01449
    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. MFR 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 AN EGD DEMONSTRATED ONE FILTER LEG EXTENDING INTO THE LUMEN OF DUODENUM. THE ENTIRE FILTER IS NOT INCLUDED ON THE IMAGE, BUT IT IS REPORTED AS A CELECT FILTER THAT HAD A 2 YEARS DWELL TIME. THE PATIENT PRESENTED WITH RIGHT UPPER QUADRANT PAIN AND THE FILTER WAS RETRIEVED ENDOVASCULARLY UTILIZING ADVANCED TECHNIQUES. LONG-TERM FOLLOW-UP DEMONSTRATED RESOLUTION OF ABDOMINAL PAIN 2 YEARS FOLLOWING RETRIEVAL. THE FILTER WAS PLACED DUE TO HIGH RISK OF THROMBOEMBOLIC DISEASE DUE TO TRAUMA, BUT BASED ON LIMITED INFORMATION PROVIDED THE EXACT REASON FOR THE FILTER LEG PERFORATION 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. 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 UPPER QUADRANT ABDOMINAL PAIN. FILTER TINES BEYOND THE WALL OF THE IVC, ABUTTING THE AORTA, PENETRATING THE DUODENUM. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN. TRANSIENT SEPSIS AFTER RETRIEVAL; RESOLVED WITH 2 WEEKS OF ANTIBIOTICS. POST-RETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVALHEMATOMA, AND CAVAL THROMBUS. 2 YEARS FOLLOW-UP: RESOLUTION OF ABDOMINAL PAIN, NO DVT/PE, NO LONG-TERM ANTICOAGULATION." 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. TRANSIENT SEPSIS AFTER RETRIEVAL; RESOLVED WITH 2 WEEKS OF ANTIBIOTICS. ADVERSE EVENTS REPORTED: SYMPTOMATIC GASTROINTESTINAL COMPLICATION; RIGHT UPPER QUADRANT ABDOMINAL PAIN.

    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 UPPER QUADRANT ABDOMINAL PAIN. FILTER TINES BEYOND THE WALL OF THE IVC, ABUTTING THE AORTA, PENETRATING THE DUODENUM. ENDOVASCULAR RETRIEVAL OF IVC FILTER; ACCESS: R IJ, R FEMORAL VEIN. TRANSIENT SEPSIS AFTER RETRIEVAL; RESOLVED WITH 2 WEEKS OF ANTIBIOTICS. POSTRETRIEVAL CT SCAN WITH IV/PO CONTRAST AT 48 HOURS; NEGATIVE FOR DUODENAL LEAK, PERICAVAL HEMATOMA, AND CAVAL THROMBUS. 2 YEARS FOLLOW-UP: RESOLUTION OF ABDOMINAL PAIN, NO DVT/PE, NO LONG-TERM ANTICOAGULATION." 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. TRANSIENT SEPSIS AFTER RETRIEVAL; RESOLVED WITH 2 WEEKS OF ANTIBIOTICS. ADVERSE EVENTS REPORTED: SYMPTOMATIC GASTROINTESTINAL COMPLICATION; RIGHT UPPER QUADRANT ABDOMINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782659 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening| R