BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6331036 · Received February 15, 2017

    Report

    Report Number
    3002808486-2017-00394
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Report Date
    November 6, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON DESCRIPTION OF EVENT AND IMAGING FROM ARTICLE. REVIEW OF IMAGING CONFIRMED TWO GRADE 3 PERFORATIONS WITH CELECT PRIMARY LEGS, ONE OF THE LEGS PENETRATING DUODENUM. A SECOND PATIENT HAD A GRADE 2 PERFORATION IN EITHER A CELECT OR A TULIP FILTER. GREATER IVC REDUCTION DURING VALSALVA IS CONSIDERED AN EFFECT OF FILTER PERFORATION RATHER THAN A CAUSE OF PERFORATION. THIS COMPLAINT REFERS TO THE SECOND PATIENT. FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL-KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT (E.G. SURGERY, CENTRAL LINE CATHETER PLACEMENT RETRIEVAL ATTEMPT) COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. 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. (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON DESCRIPTION OF EVENT AND IMAGING FROM ARTICLE. REVIEW OF IMAGING CONFIRMED TWO GRADE 3 PERFORATIONS WITH CELECT PRIMARY LEGS, ONE OF THE LEGS PENETRATING DUODENUM. A SECOND PATIENT HAD A GRADE 2 PERFORATION IN EITHER A CELECT OR A TULIP FILTER. GREATER IVC REDUCTION DURING VALSALVA IS CONSIDERED AN EFFECT OF FILTER PERFORATION RATHER THAN A CAUSE OF PERFORATION. THIS COMPLAINT REFERS TO THE SECOND PATIENT. FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL-KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT (E.G. SURGERY, CENTRAL LINE CATHETER PLACEMENT RETRIEVAL ATTEMPT) COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. 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 ARTICLE: MINOR PENETRATION (GRADE 2), THE STRUT IS OUTSIDE THE IVC LUMEN WALL WITHIN RETROPERITONEUM, AN HALO IS OBSERVED AROUND THE STRUT, SEPARATING IT FROM THE CONTRAST FILLED LUMEN . NO INFORMATION ON RETRIEVABILITY IS AVAILABLE FROM THE ARTICLE. PATIENT OUTCOME: ACCORDING TO THE ARTICLE NO ADVERSE EFFECTS ON THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113837 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1