BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5296975 · Received December 15, 2015

    Report

    Report Number
    3002808486-2015-00170
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Date of Event
    November 13, 2013
    Report Date
    August 2, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER. LOT# UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112199, K121057 OR K121629. SUMMARY OF INVESTIGATION FINDINGS: NO IMAGING PROVIDED AND PATIENT'S MEDICAL RECORDS ARE UNKNOWN AT THIS TIME. CONSEQUENTLY IT IS NOT POSSIBLE TO COMMENT ON THE REPORTED FAILED RETRIEVAL APPROX. 9 MONTHS AFTER FILTER PLACEMENT. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL RETRIEVALS OF FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. DIFFICULT FILTER RETRIEVAL DUE TO EMBEDMENT OF FILTER LEGS IN THE IVC WALL IS A WELL-KNOWN RISK IN THE LITERATURE. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL ENDOVASCULAR RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. RPN AND LOT# ARE UNKNOWN, BUT THERE IS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER AS CATALOG NUMBER IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112199, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. WILLIAM COOK (B)(4) (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REFERENCE # (B)(4). CORRECTED DATA: ADVERSE EVENT TO PRODUCT PROBLEM. SERIOUS INJURY TO MALFUNCTION. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "CELECT FILTER IMPLANT - CANNOT BE RETRIEVED, PAIN, NAUSEA, ANXIETY, VOMITING, SKIN BLISTERING AND PEELING AROUND EXTRACTION SITE. SECOND RETRIEVAL ATTEMPT SUCCESSFUL". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. 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.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2013 AT THE (B)(6). FAILED RETRIEVAL OF FILTER ON (B)(6) 2013. PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2013 AT (B)(6). FAILED RETRIEVAL OF FILTER ON (B)(6) 2013." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 08/04/2016 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED THE DEVICE IMPLANT ON (B)(6) 2013 AS PROPHYLAXIS FOR DVT BEFORE TOTAL JOINT SURGERY OF THE RIGHT KNEE. AN UNSUCCESSFUL ATTEMPT TO RETRIEVE THE FILTER ALLEGEDLY OCCURRED ON (B)(6) 2013. THE PLAINTIFF ALLEGES SEVERE PAIN, ANXIETY, NAUSEA AND VOMITING. THE FILTER WAS ALLEGEDLY SUCCESSFULLY RETRIEVED ON (B)(6) 2013. THE PLAINTIFF ALLEGES SEVERE PAIN, NAUSEA AND VOMITING, SKIN BLISTERING AND PEELING AROUND THE EXTRACTION SITE. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827531 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening