BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5720411 · Received June 13, 2016

    Report

    Report Number
    1820334-2016-00426
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    March 25, 2016
    Report Date
    May 24, 2016
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: SAVIOR OR SADIST: IMAGING AND INTERVENTION OF RECURRENTLY EMBOLIZED INFERIOR VANA CAVA FILTER FRAGMENTS, THE JOURNAL OF EMERGENCY MEDICINE, VOL. 45, NO. 3, PP. E83¿E86, 2013. (B)(4). CORRECTION TO INITIAL WAS FILED WITHIN THE 30 DAY TIME FRAME REGARDLESS OF CORRECTED DATE. INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN, ACCORDINGLY A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS AND PRECAUTIONS, AND CORRECT DEPLOYMENT PROCEDURE. THE EXACT IFU IS DEPENDENT ON PRODUCT SIZE AND PLACEMENT APPROACH. WITHOUT THE EXACT DEVICE PRODUCT CODE, WE CANNOT DETERMINE THE EXACT IFU. HOWEVER, IN EACH IFU, PERFORATION OF VENA CAVA WALL IS LISTED AS A POTENTIAL ADVERSE EVENT. DESIGN TESTING WAS CONDUCTED TO CONFIRM ADEQUATE FATIGUE STRENGTH IN THE FILTER STRUTS AND THE PRODUCT IS INSPECTED FOR 100% VERIFICATION OF LENGTH, POSITION, SPACING AND BEVEL TYPE OF THE BARBS. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: SAVIOR OR SADIST: IMAGING AND INTERVENTION OF RECURRENTLY EMBOLIZED INFERIOR VANA CAVA FILTER FRAGMENTS, THE JOURNAL OF EMERGENCY MEDICINE, VOL. 45, NO. 3, PP. E83¿E86, 2013. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED IN THE JOURNAL ARTICLE "SAVIOR OR SADIST: IMAGING AND INTERVENTION OF RECURRENTLY EMBOLIZED INFERIOR VANA CAVA FILTER FRAGMENTS, THE JOURNAL OF EMERGENCY MEDICINE, VOL. 45, NO. 3, PP. E83¿E86, 2013": "A (B)(6) FEMALE WITH PULMONARY HYPERTENSION SECONDARY TO MULTIPLE PULMONARY EMBOLI AND STATUS POST PULMONARY THROMBOENDARTERECTOMY WITH BIRD¿S NEST INFERIOR VENA CAVA FILTER PLACEMENT PRESENTED TO HER PRIMARY CARE PHYSICIAN AT OUR HOSPITAL WITH INCREASING DYSPNEA ON EXERTION AND PALPITATIONS FOR 3 DAYS. THE PATIENT REPORTED EXPERIENCING EXTREME ¿¿SHORTNESS OF BREATH¿¿ AFTER WALKING APPROXIMATELY 2 MILES, A DISTANCE SHE HAD PREVIOUSLY COMPLETED WITH EASE. IN ADDITION, THE PATIENT REPORTED A NEW ¿¿RACING HEART SENSATION.¿¿ THE PATIENT SPECIFICALLY DENIED CHEST PAIN, RADIATION, OR DIAPHORESIS. IN AN ATTEMPT TO LIMIT RADIATION EXPOSURE DUE TO AN EXCESSIVE NUMBER OF COMPUTED TOMOGRAPHY (CT) SCANS IN THE PAST, AND WITH A PRIMARY COMPLAINT OF PALPITATIONS, THE PATIENT INITIALLY UNDERWENT OUTPATIENT CARDIAC MAGNETIC RESONANCE IMAGING TO EVALUATE FOR STRUCTURAL CARDIAC ABNORMALITIES, WHICH DEMONSTRATED A METALLIC ARTIFACT WITHIN THE RIGHT VENTRICLE (FIGURE 1). DUE TO THE POTENTIAL HAZARD OF AN UNRECOGNIZED METALLIC OBJECT, THE DIAGNOSTIC IMAGING PROCEDURE WAS IMMEDIATELY TERMINATED. THE PATIENT WAS REFERRED TO THE EMERGENCY DEPARTMENT, WHERE A SINGLE CHEST RADIOGRAPH WAS SUBSEQUENTLY OBTAINED AND DEMONSTRATED A SINGLE CURVILINEAR DENSITY ADJACENT TO THE RIGHT HILUM (FIGURE 2). IN AN EFFORT TO BETTER CHARACTERIZE ANY POTENTIAL METALLIC OBJECT WITHIN THE RIGHT VENTRICLE, THE PATIENT UNDERWENT CT ANGIOGRAPHY OF THE CHEST, ABDOMEN, AND PELVIS WITH INTRAVENOUS CONTRAST MATERIAL. THE STUDY DEMONSTRATED TWO LINEAR HIGH-ATTENUATION FOREIGN BODIES WITHIN THE RIGHT VENTRICLE (FIGURE 3), AS WELL AS MULTIPLE CURVILINEAR HIGH-DENSITY FOREIGN BODIES WITHIN THE RIGHT INTERLOBAR AND SEGMENTAL PULMONARY ARTERIES (FIGURE 4). ADDITIONALLY, WITHIN THE INFERIOR VENA CAVA, THERE WAS EVIDENCE OF A FRACTURED BIRD¿S NEST INFERIOR VENA CAVA FILTER (FIGURE 5), SUGGESTING THAT THE HIGH-ATTENUATION MATERIALS WITHIN THE RIGHT VENTRICLE AND RIGHT PULMONARY ARTERIES WERE EMBOLIZED FRACTURED FILTER FRAGMENTS. THE PATIENT UNDERWENT CATHETER RETRIEVAL WITH THE RECOVERY OF ONE METALLIC FRAGMENT FROM THE RIGHT VENTRICLE AND SIX METALLIC FRAGMENTS FROM THE RIGHT PULMONARY ARTERIES. NUMEROUS ATTEMPTS WERE MADE TO RETRIEVE TWO RESIDUAL FRAGMENTS WITHIN THE RIGHT VENTRICLE AND RIGHT PULMONARY ARTERIES, HOWEVER, THE PATIENT DEVELOPED RECURRENT VENTRICULAR TACHYCARDIA AND ADDITIONAL ATTEMPTS WERE ABORTED. MULTIPLE IRREGULAR WIRE FRAGMENTS WERE SUBMITTED TO SURGICAL PATHOLOGY, CONFIRMING INITIAL SUSPICIONS FOR FRACTURED BIRD¿S NEST FILTER FRAGMENTS. SHORTLY AFTER THE PROCEDURE, THE PATIENT NOTED COMPLETE RESOLUTION OF HER PALPATIONS AND DYSPNEA. THE PATIENT PRESENTED AGAIN TO THIS HOSPITAL 5 MONTHS LATER WITH RECURRENT DYSPNEA ON EXERTION. AT THIS POINT, THE PATIENT REPORTED NEW ¿¿SHORTNESS OF BREATH¿¿ AFTER CLIMBING A SINGLE FLIGHT OF STAIRS. THE PATIENT UNDERWENT REPEATED CT ANGIOGRAPHY OF THE CHEST, ABDOMEN, AND PELVIS AFTER THE ADMINISTRATION OF INTRAVENOUS CONTRAST MATERIAL, WHICH AGAIN DEMONSTRATED NUMEROUS, PERHAPS NEW, HIGH-DENSITY FRAGMENTS WITHIN THE RIGHT PULMONARY ARTERY. THE PATIENT UNDERWENT REPEATED CATHETER RETRIEVAL WITH THE SUCCESSFUL REMOVAL OF THREE ADDITIONAL FRAGMENTS FROM THE RIGHT PULMONARY ARTERIES. SEVERAL MONTHS LATER, THE PATIENT UNDERWENT SURGICAL REMOVAL OF THE BIRD¿S NEST INFERIOR VENA CAVA FILTER WITH REPAIR OF THE INFERIOR VENA CAVA, WITHOUT COMPLICATION. THE PATIENT HAS NOT EXPERIENCED PALPITATIONS OR DYSPNEA FOR THE PAST 2 YEARS."

    Description of Event or Problem · 1

    AS STATED IN THE JOURNAL ARTICLE "SAVIOR OR SADIST: IMAGING AND INTERVENTION OF RECURRENTLY EMBOLIZED INFERIOR VANA CAVA FILTER FRAGMENTS, THE JOURNAL OF EMERGENCY MEDICINE, VOL. 45, NO. 3, PP. E83¿E86, 2013" : "A (B)(6) FEMALE WITH PULMONARY HYPERTENSION SECONDARY TO MULTIPLE PULMONARY EMBOLI AND STATUS POST PULMONARY THROMBOENDARTERECTOMY WITH BIRD¿S NEST INFERIOR VENA CAVA FILTER PLACEMENT PRESENTED TO HER PRIMARY CARE PHYSICIAN AT OUR HOSPITAL WITH INCREASING DYSPNEA ON EXERTION AND PALPITATIONS FOR 3 DAYS. THE PATIENT REPORTED EXPERIENCING EXTREME ¿¿SHORTNESS OF BREATH¿¿ AFTER WALKING APPROXIMATELY 2 MILES, A DISTANCE SHE HAD PREVIOUSLY COMPLETED WITH EASE. IN ADDITION, THE PATIENT REPORTED A NEW ¿¿RACING HEART SENSATION.¿¿ THE PATIENT SPECIFICALLY DENIED CHEST PAIN, RADIATION, OR DIAPHORESIS. IN AN ATTEMPT TO LIMIT RADIATION EXPOSURE DUE TO AN EXCESSIVE NUMBER OF COMPUTED TOMOGRAPHY (CT) SCANS IN THE PAST, AND WITH A PRIMARY COMPLAINT OF PALPITATIONS, THE PATIENT INITIALLY UNDERWENT OUTPATIENT CARDIAC MAGNETIC RESONANCE IMAGING TO EVALUATE FOR STRUCTURAL CARDIAC ABNORMALITIES, WHICH DEMONSTRATED A METALLIC ARTIFACT WITHIN THE RIGHT VENTRICLE. DUE TO THE POTENTIAL HAZARD OF AN UNRECOGNIZED METALLIC OBJECT, THE DIAGNOSTIC IMAGING PROCEDURE WAS IMMEDIATELY TERMINATED. THE PATIENT WAS REFERRED TO THE EMERGENCY DEPARTMENT, WHERE A SINGLE CHEST RADIOGRAPH WAS SUBSEQUENTLY OBTAINED AND DEMONSTRATED A SINGLE CURVILINEAR DENSITY ADJACENT TO THE RIGHT HILUM. IN AN EFFORT TO BETTER CHARACTERIZE ANY POTENTIAL METALLIC OBJECT WITHIN THE RIGHT VENTRICLE, THE PATIENT UNDERWENT CT ANGIOGRAPHY OF THE CHEST, ABDOMEN, AND PELVIS WITH INTRAVENOUS CONTRAST MATERIAL. THE STUDY DEMONSTRATED TWO LINEAR HIGH-ATTENUATION FOREIGN BODIES WITHIN THE RIGHT VENTRICLE, AS WELL AS MULTIPLE CURVILINEAR HIGH-DENSITY FOREIGN BODIES WITHIN THE RIGHT INTERLOBAR AND SEGMENTAL PULMONARY ARTERIES. ADDITIONALLY, WITHIN THE INFERIOR VENA CAVA, THERE WAS EVIDENCE OF A FRACTURED BIRD¿S NEST INFERIOR VENA CAVA FILTER, SUGGESTING THAT THE HIGH-ATTENUATION MATERIALS WITHIN THE RIGHT VENTRICLE AND RIGHT PULMONARY ARTERIES WERE EMBOLIZED FRACTURED FILTER FRAGMENTS. THE PATIENT UNDERWENT CATHETER RETRIEVAL WITH THE RECOVERY OF ONE METALLIC FRAGMENT FROM THE RIGHT VENTRICLE AND SIX METALLIC FRAGMENTS FROM THE RIGHT PULMONARY ARTERIES. NUMEROUS ATTEMPTS WERE MADE TO RETRIEVE TWO RESIDUAL FRAGMENTS WITHIN THE RIGHT VENTRICLE AND RIGHT PULMONARY ARTERIES, HOWEVER, THE PATIENT DEVELOPED RECURRENT VENTRICULAR TACHYCARDIA AND ADDITIONAL ATTEMPTS WERE ABORTED. MULTIPLE IRREGULAR WIRE FRAGMENTS WERE SUBMITTED TO SURGICAL PATHOLOGY, CONFIRMING INITIAL SUSPICIONS FOR FRACTURED BIRD¿S NEST FILTER FRAGMENTS. SHORTLY AFTER THE PROCEDURE, THE PATIENT NOTED COMPLETE RESOLUTION OF HER PALPATIONS AND DYSPNEA. THE PATIENT PRESENTED AGAIN TO THIS HOSPITAL 5 MONTHS LATER WITH RECURRENT DYSPNEA ON EXERTION. AT THIS POINT, THE PATIENT REPORTED NEW ¿¿SHORTNESS OF BREATH¿¿ AFTER CLIMBING A SINGLE FLIGHT OF STAIRS. THE PATIENT UNDERWENT REPEATED CT ANGIOGRAPHY OF THE CHEST, ABDOMEN, AND PELVIS AFTER THE ADMINISTRATION OF INTRAVENOUS CONTRAST MATERIAL, WHICH AGAIN DEMONSTRATED NUMEROUS, PERHAPS NEW, HIGH-DENSITY FRAGMENTS WITHIN THE RIGHT PULMONARY ARTERY. THE PATIENT UNDERWENT REPEATED CATHETER RETRIEVAL WITH THE SUCCESSFUL REMOVAL OF THREE ADDITIONAL FRAGMENTS FROM THE RIGHT PULMONARY ARTERIES. SEVERAL MONTHS LATER, THE PATIENT UNDERWENT SURGICAL REMOVAL OF THE BIRD¿S NEST INFERIOR VENA CAVA FILTER WITH REPAIR OF THE INFERIOR VENA CAVA, WITH- OUT COMPLICATION. THE PATIENT HAS NOT EXPERIENCED PALPITATIONS OR DYSPNEA FOR THE PAST 2 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374476 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention