BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8955446 · Received September 3, 2019

    Report

    Report Number
    1820334-2019-02165
    Event Type
    Injury
    Date Received
    September 3, 2019
    Report Date
    September 14, 2020
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION: INVESTIGATION WAS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE PATIENT ALLEGES MIGRATION, TILT, VENA CAVA PERFORATION, FRACTURE, DEVICE IS UNABLE TO BE RETRIEVED, ORGAN PERFORATION-MESENTERIC, AND IVC STENOSIS. THE PATIENT FURTHER ALLEGES ANXIETY, MENTAL ANGUISH, STRESS, LIMITED MOBILITY, AND WORRY. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE PATIENT ALLEGATION. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THE GIANTURCO-ROEHM BIRD¿S NEST VENA CAVA FILTERS ARE PLACED VIA STANDARD PERCUTANEOUS ENTRY (SELDINGER) TECHNIQUE. INTRODUCTION OF THE GIANTURCO-ROEHM BIRD¿S NEST FILTER IS ACCOMPLISHED THROUGH A SERIES OF CONTROLLED STEPS WHICH ALLOW THE OPERATOR TO ALTER PLACEMENT TO ACCOMMODATE ANATOMIC VARIATIONS. THE GIANTURCO-ROEHM BIRD¿S NEST FILTER¿S HOOK WIRE DESIGN AND TWO PAIR OF ¿V¿ SHAPED STRUTS HOLD THE FILTERING WIRES IN PLACE AND FACILITATES A SECURE FIXATION IN THE VENA CAVA WITH A MINIMAL RISK OF MIGRATION OR VESSEL PERFORATION. THE BIRD¿S NEST® VENA CAVA FILTERS ARE INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM VIA PLACEMENT IN THE VENA CAVA IN THE FOLLOWING SITUATIONS: PULMONARY THROMBOEMBOLISM WHEN ANTICOAGULANTS ARE CONTRAINDICATED, FAILURE OF ANTICOAGULANT THERAPY IN THROMBOEMBOLIC DISEASES, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED, PROPHYLACTICALLY IN PATIENTS WITH CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED OR IS CONTRAINDICATED. RISK BENEFIT ANALYSIS (RBA) RA82_RBA WAS COMPLETED TO ASSESS THE BENEFIT; RISK RATIO OF THE BIRD'S NEST FILTER. THE RBA STATES THAT "IT IS THE OPINION OF COOK INC. THAT THE MEDICAL BENEFITS OF THE BIRD'S NEST FILTER OUTWEIGH THE RESIDUAL RISKS TO THE PATIENT. IT IS EXPECTED THAT SOME PATIENTS WITH INDWELLING IVC FILTERS MAY STILL EXPERIENCE PULMONARY EMBOLI (THOUGH NOT NECESSARILY FATAL EMBOLI). A LITERATURE SEARCH FOR RELEVANT CLINICAL STUDIES SUGGESTS THAT PE RATE OF 1 TO 2 PERCENT IN PATIENTS WITH INDWELLING IVC FILTERS; IN THE BIRD'S NEST FILTER CLINICAL STUDY UPON WHICH THE FDA APPROVAL WAS BASED, 1% OF PATIENTS WITH A BIRD'S NEST FILTER EXPERIENCED PE. THE RATES OF PE REFLECTED IN OUR COMPLAINTS DATA IS SIGNIFICANTLY BELOW THE EXPECTED RATE OF PE. IT IS CONCLUDED THAT THESE DEVICES MEET THE PERFORMANCE REQUIREMENTS NECESSARY TO PERFORM THEIR INTENDED USE SAFELY AND EFFECTIVELY. 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. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: A2, B2, B5, B6, H6. H6 DEVICE CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (3191) WAS SELECTED FOR THE ALLEGED PERFORATION. INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE PATIENT ALLEGATION. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN; HOWEVER, 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. THE GIANTURCO-ROEHM BIRD¿S NEST VENA CAVA FILTERS ARE PLACED VIA STANDARD PERCUTANEOUS ENTRY (SELDINGER) TECHNIQUE. INTRODUCTION OF THE GIANTURCO-ROEHM BIRD¿S NEST FILTER IS ACCOMPLISHED THROUGH A SERIES OF CONTROLLED STEPS WHICH ALLOW THE OPERATOR TO ALTER PLACEMENT TO ACCOMMODATE ANATOMIC VARIATIONS. THE GIANTURCO-ROEHM BIRD¿S NEST FILTER¿S HOOK WIRE DESIGN AND TWO PAIR OF ¿V¿ SHAPED STRUTS HOLD THE FILTERING WIRES IN PLACE AND FACILITATES A SECURE FIXATION IN THE VENA CAVA WITH A MINIMAL RISK OF MIGRATION OR VESSEL PERFORATION. THE BIRD¿S NEST® VENA CAVA FILTERS ARE INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM VIA PLACEMENT IN THE VENA CAVA IN THE FOLLOWING SITUATIONS: PULMONARY THROMBOEMBOLISM WHEN ANTICOAGULANTS ARE CONTRAINDICATED, FAILURE OF ANTICOAGULANT THERAPY IN THROMBOEMBOLIC DISEASES, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED, PROPHYLACTICALLY IN PATIENTS WITH CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED OR IS CONTRAINDICATED. INSTRUCTIONS FOR USE DOCUMENTS THE CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS FOR THE GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER. POTENTIAL ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO: FILTER MIGRATION (MAY OCCUR IF PROPER ANCHORING TECHNIQUES ARE NOT UTILIZED) INFERIOR VENA CAVA THROMBOSIS. PERFORATION OF VENA CAVA WALL HEMATOMA AT PUNCTURE SITE. RISK BENEFIT ANALYSIS (RBA) WAS COMPLETED TO ASSESS THE BENEFIT; RISK RATIO OF THE BIRD'S NEST FILTER. THE RBA STATES THAT "IT IS THE OPINION OF COOK INC. THAT THE MEDICAL BENEFITS OF THE BIRD'S NEST FILTER OUTWEIGH THE RESIDUAL RISKS TO THE PATIENT. IT IS EXPECTED THAT SOME PATIENTS WITH INDWELLING IVC FILTERS MAY STILL EXPERIENCE PULMONARY EMBOLI (THOUGH NOT NECESSARILY FATAL EMBOLI). A LITERATURE SEARCH FOR RELEVANT CLINICAL STUDIES SUGGESTS THAT PE RATE OF 1 TO 2 PERCENT IN PATIENTS WITH INDWELLING IVC FILTERS; IN THE BIRD'S NEST FILTER CLINICAL STUDY UPON WHICH THE FDA APPROVAL WAS BASED, 1% OF PATIENTS WITH A BIRD'S NEST FILTER EXPERIENCED PE. THE RATES OF PE REFLECTED IN OUR COMPLAINTS DATA IS SIGNIFICANTLY BELOW THE EXPECTED RATE OF PE. IT IS CONCLUDED THAT THESE DEVICES MEET THE PERFORMANCE REQUIREMENTS NECESSARY TO PERFORM THEIR INTENDED USE SAFELY AND EFFECTIVELY. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. 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

    THE PATIENT ALLEGES MIGRATION, TILT, VENA CAVA PERFORATION, FRACTURE, DEVICE IS UNABLE TO BE RETRIEVED, ORGAN PERFORATION-MESENTERIC, AND IVC STENOSIS. THE PATIENT FURTHER ALLEGES ANXIETY, MENTAL ANGUISH, STRESS, LIMITED MOBILITY, AND WORRY.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2009 VIA LEFT COMMON FEMORAL VEIN DUE TO RIGHT LOWER EXTREMITY DVT (PER THE IMPLANT OPERATIVE REPORT). PER A CT (COMPUTED TOMOGRAPHY) SCAN OF THE ABDOMEN DATED (B)(6) 2017, ¿THE PATIENT HAS AN IVC FILTER WHICH APPEARS TO BE FRAGMENTED AND DOES NOT MAINTAIN ITS USUAL SHAPE. THIS IVC FILTER MAY BE FRACTURED. THE TIP OF THE IVC FILTER LIES WITHIN THE RIGHT RENAL VEIN WITH SOME OF THE LEGS ON THE LEFT LATERAL SIDE PROTRUDING INTO THE LEFT RENAL VEIN. ONE PARTICULAR LEG OF THE IVC FILTER PROTRUDES THROUGH THE LUMEN OF THE IVC APPROXIMATELY 1 TO 2 CM AND PROTRUDES INTO THE CENTRAL MESENTERIC SPACE BUT DOES NOT APPEAR TO CONTACT ANY MAJOR ARTERIES. THE IVC FILTER ITSELF IS NOT EXPANDED AS ONE WOULD EXPECT AND THIS MAY BE CAUSING COMPLETE COLLAPSE OF THE INFRARENAL IVC FILTER. THIS MAY BE BETTER EVALUATED IN THE SENSE OF ITS FRACTURING ON PLAIN RADIOGRAPHS AS IT IS DIFFICULT TO TELL THE COMPLEXITY ON THIS STUDY. IF DESIRED, CONSIDER PERFORMING AP AND LATERAL PLAIN RADIOGRAPHS POSSIBLY CONED DOWN TO THE IVC FILTER AND ADDITIONAL COMMENTS CAN BE MADE IN REGARDS TO ITS INTEGRITY. ¿IMPRESSION: NO ACUTE ABDOMINAL PATHOLOGY. SIGNIFICANT DISPLACEMENT OF AN IVC FILTER WITH POSSIBLE FRACTURING. THE IVC FILTER IS NOT WITHIN ITS INTENDED SHAPE AND RESIDES WITHIN THE RENAL ARTERIES ITSELF PARTICULARLY ON THE RIGHT.¿

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN; HOWEVER, 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. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION AND/OR NO DEVICE FAILURE PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT RECEIVED A BIRDS NEST INFERIOR VENA CAVA FILTER DEVICE ON (B)(6) 2009. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751527 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O