BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8472492 · Received April 2, 2019

    Report

    Report Number
    3002808486-2019-00348
    Event Type
    Injury
    Date Received
    April 2, 2019
    Report Date
    June 13, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113. DEVICE CODE: 3191 - APPROPRIATE CODE NOT AVAILABLE FOR PERFORATION OF ORGAN(S). BASED ON ARTICLE: "VENA CAVA FILTER RETRIEVAL WITH AORTO-ILIAC ARTERIAL STRUT PENETRATION", HOLLY ET AL., 2018 SUMMARY OF INVESTIGATIONAL FINDINGS: COMPLAINT EVENT IDENTIFIED IN ARTICLE WITH THE PURPOSE TO EVALUATE THE SAFETY AND TECHNICAL SUCCESS OF INFERIOR VENA CAVA FILTER RETRIEVAL IN THE SETTING OF AORTO-ILIAC ARTERIAL STRUT PENETRATION. IFU MENTIONS, VENA CAVA WALL PENETRATION/PERFORATION HAS BEEN REPORTED AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER) AND IFU WARNS IN CONNECTION WITH THIS, POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. BASED ON THE LIMITED INFORMATION PROVIDED IT WOULD BE INAPPROPRIATE TO SPECULATE WHAT CAUSED THE REPORTED EVENTS AND THERE IS NO EVIDENCE TO SUGGEST DEVICE FAILURE. THE ARTICLE DOES REPORT "TECHNICAL SUCCESS OF VENA CAVA RETRIEVAL WAS 100%, WITHOUT ANY MAJOR ADVERSE EVENTS" RETRIEVAL WAS SUCCESSFULLY ACCOMPLISHED WITH WIRE LOOP, LASER (16F). PHYSICIAN PRACTICE GUIDELINES AND PUBLISHED GUIDANCE FROM REGULATORY AGENCIES RECOMMEND THAT PATIENTS WITH INDWELLING FILTERS UNDERGO ROUTINE FOLLOW-UP. THE RISKS/BENEFITS OF FILTER RETRIEVAL SHOULD BE CONSIDERED FOR EACH PATIENT DURING FOLLOW-UP. "ARTICLE CONCLUSION FINDINGS SUGGEST THAT CHRONICALLY INDWELLING IVC FILTERS WITH AORTO-ILIAC ARTERIAL STRUT PENETRATION CAN BE SAFELY RETRIEVED ENDOVASCULARLY. HOWEVER, GIVEN THE SMALL SAMPLE SIZE AND HETEROGENEOUS METHODS, THE RESULTS SUGGEST RECOMMENDING SUCH FILTER RETRIEVALS BEING PERFORMED BY EXPERIENCED OPERATORS WITH ACCESS TO MATERIALS SUCH AS STENT GRAFTS AND OCCLUSION BALLOONS IN THE SETTING OF AN UNEXPECTED COMPLICATION." NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404. REGISTRATION NO.: 3005580113. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "INDICATION FOR IVC FILTER PLACEMENT: DVT, HEMATOMA ON ANTICOAGULATION. IMPLANT DURATION: 19 MONTHS." REMOVAL TECHNIQUE (SHEATH SIZE)= WIRE LOOP, LASER (16F). PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269078 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening