BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4036814 · Received August 20, 2014

    Report

    Report Number
    1820334-2014-00388
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 30, 2014
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH CATALOG # IS UNK BUT COULD BE EITHER K072240 OR K043509. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    LOT - UNKNOWN AS NOT PROVIDED BY REPORTER. CATALOG # - UNKNOWN AS NOT PROVIDED BY REPORTER. EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. (B)(4). ALTHOUGH CATALOG # IS UNKNOWN BUT COULD BE EITHER K072240 OR K043509.

    Additional Manufacturer Narrative · 1

    LOT - UNKNOWN AS NOT PROVIDED BY REPORTER. CATALOG # - UNKNOWN AS NOT PROVIDED BY REPORTER. EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. (B)(4) ALTHOUGH CATALOG # IS UNKNOWN BUT COULD BE EITHER K072240 OR K043509. EVENT EVALUATION: A REVIEW OF INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, AND TRENDS WAS CONDUCTED DURING THE INVESTIGATION. THERE IS NO EVIDENCE TO SUGGEST THAT DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS ALL FOUR FILTER LEGS PERFORATED IVC, THE PAIN IS MOST LIKELY RELATED TO DUODENAL PERFORATION. FILTER TILTED AND THREE FILTER LEGS FRACTURED (ONE SETTLED IN BONE AND TWO OUTSIDE IVC). ONE FRACTURE CAUSED HYPERTROPHIC BONE REACTION. MILD STENOSIS OF IVC WAS NOTED AFTER FILTER RETRIEVAL, HOWEVER, NOT ASSESSED TO BE SIGNIFICANT. THE FILTER WAS RETRIEVED, HOWEVER, FRACTURED PIECES REMAINED INSIDE THE PATIENT. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN AT THIS TIME. A REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE: IN POTENTIAL ADVERSE EVENTS ARE MENTIONED: DAMAGE TO THE VENA CAVA, PULMONARY EMBOLISM, FILTER EMBOLIZATION, VENA CAVA PERFORATION, VENA CAVA OCCLUSION OR THROMBOSIS, HEMORRHAGE, HEMATOMA AT VASCULAR ACCESS SITE, INFECTION AT VASCULAR ACCESS SITE, DEATH. IT IS COOKS EXPERIENCE THAT FRACTURE IS SECONDARY TO PERFORATION OF IVC. FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. SEVERAL CASE REPORTS IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. CHANGES TO THE FILTER CONFIGURATION AND TO THE FILTER PLACEMENT, IS KNOWN TO CAUSE STRESS AND POSSIBLY FRACTURE TO THE FILTER WIRES DUE TO E.G. RESPIRATORY MOVEMENTS. ALSO SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD ALSO CONTRIBUTE TO CHANGE IN FILTER CONFIGURATION. FRACTURE OF THE WIRE IS AN UNCOMMON, BUT KNOWN RISK IN RELATION TO FILTER IMPLANT. BASED ON THE ABOVE, THE EXACT ROOT CAUSE FOR WHAT CAUSED THE FILTER PERFORATION AND FILTER FRACTURE IS UNKNOWN. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    (B)(4) INDICATED THAT A FEMALE PT HAD A GUNTHER IVC FILTER PLACED ON (B)(6) 2006 FOR ON-LABEL INDICATION (PE AND BLEEDING) AT ANOTHER HOSPITAL. THE PT HAD LONG TERM PROBLEMS WITH BACK PAIN AND ULTIMATELY HAD A CT SCAN DONE RECENTLY SHOWING FRACTURED FILTER LEG WITH PENETRATION INTO VERTEBRAL BODY, INTENSE OSSEOUS REACTION AROUND FRACTURED STRUT, LIKELY CAUSE OF PAIN. THE PT ALSO HAD DUODENAL PENETRATION BY ANOTHER STRUT. THE FILTER WAS REMOVED ON (B)(6) 2014 BUT THE FRACTURED FRAGMENTS (ONE THICK WIRE LEG FRAGMENT, AND ONE THIN WIRE "TULIP" FRAGMENT) WERE EXTRAVASCULAR AND COULD NOT BE RETRIEVED. THE PHYSICIAN STATED IN AN EMAIL THAT THE REMAINING FRAGMENT IS TO BE LEFT IN PLACE GIVEN THE COMPLEXITY OF PURSUING IT SURGICALLY AND THE LACK OF SYMPTOMS; HER PRIOR PAIN HAS RESOLVED AND SHE IS VERY HAPPY.

    Description of Event or Problem · 1

    FDA MAUDE REPORT MW5036812 INDICATED THAT A FEMALE PATIENT HAD A GUNTHER IVC FILTER PLACED ON (B)(6) 2006 FOR ON-LABEL INDICATION (PE AND BLEEDING) AT ANOTHER HOSPITAL. THE PATIENT HAD LONG TERM PROBLEMS WITH BACK PAIN AND ULTIMATELY HAD A CT SCAN DONE RECENTLY SHOWING FRACTURED FILTER LEG WITH PENETRATION INTO VERTEBRAL BODY, INTENSE OSSEOUS REACTION AROUND FRACTURED STRUT, LIKELY CAUSE OF PAIN. THE PATIENT ALSO HAD DUODENAL PENETRATION BY ANOTHER STRUT. THE FILTER WAS REMOVED ON (B)(6) 2014 BUT THE FRACTURED FRAGMENTS (ONE THICK WIRE LEG FRAGMENT, AND ONE THIN WIRE "TULIP" FRAGMENT) WERE EXTRAVASCULAR AND COULD NOT BE RETRIEVED. THE PHYSICIAN STATED IN AN EMAIL THAT THE REMAINING FRAGMENT IS TO BE LEFT IN PLACE GIVEN THE COMPLEXITY OF PURSUING IT SURGICALLY AND THE LACK OF SYMPTOMS; HER PRIOR PAIN HAS RESOLVED AND SHE IS VERY HAPPY.

    Description of Event or Problem · 1

    FDA MAUDE REPORT MW5036812 INDICATED THAT A FEMALE PATIENT HAD A GUNTHER IVC FILTER PLACED ON 06/30/2006 FOR ON-LABEL INDICATION (PE AND BLEEDING) AT ANOTHER HOSPITAL. THE PATIENT HAD LONG TERM PROBLEMS WITH BACK PAIN AND ULTIMATELY HAD A CT SCAN DONE RECENTLY SHOWING FRACTURED FILTER LEG WITH PENETRATION INTO VERTEBRAL BODY, INTENSE OSSEOUS REACTION AROUND FRACTURED STRUT, LIKELY CAUSE OF PAIN. THE PATIENT ALSO HAD DUODENAL PENETRATION BY ANOTHER STRUT. THE FILTER WAS REMOVED ON (B)(6) 2014 BUT THE FRACTURED FRAGMENTS (ONE THICK WIRE LEG FRAGMENT, AND ONE THIN WIRE "TULIP" FRAGMENT) WERE EXTRAVASCULAR AND COULD NOT BE RETRIEVED. THE PHYSICIAN STATED IN AN EMAIL THAT THE REMAINING FRAGMENT IS TO BE LEFT IN PLACE GIVEN THE COMPLEXITY OF PURSUING IT SURGICALLY AND THE LACK OF SYMPTOMS; HER PRIOR PAIN HAS RESOLVED AND SHE IS VERY HAPPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503168 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Required Intervention