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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CORPORATION UNKNOWN VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKFILTER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Perforation of Vessels (2135)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
As reported, a patient underwent placement of an unknown cordis inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned including, but not limited to filter perforation.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The cordis vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
 
Event Description
As reported by the legal brief, a patient underwent placement of an unspecified vena cava filter manufactured by cordis.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter perforation.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will suffer significant medical expenses, pain and suffering and other damages.
 
Manufacturer Narrative
As reported, a patient underwent placement of an unspecified cordis inferior vena cava (ivc) filter.The indication for filter insertion has not been provided.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter perforation.Per the patient profile form (ppf), the cordis type filter was identified per medical imaging.The exact implant date is unknown.Two images were received that appear to show an ivc filter.The patient reports perforation of filter struts outside the ivc, and anxiety related to the filter.The filter remains implanted thus unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The cordis vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
 
Event Description
As reported by the legal brief, a patient underwent placement of an unspecified vena cava filter manufactured by cordis.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter perforation.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will suffer significant medical expenses, pain and suffering and other damages.According to the information received in the patient profile form (ppf), a cordis type inferior vena cava (ivc) filter was identified per scan imaging done.The type of filter was not identified, and the exact implant date is unknown.The additional information received included two images of an abdominal computerized tomography (ct) scan that appear to show an inferior vena cava filter; however, a radiology report was not provided.The patient reports perforation of filter struts outside the ivc, becoming aware of these events approximately sixteen years and seven months after the filter implantation, and further experienced anxiety related to the filter.
 
Event Description
As reported by the legal brief, a patient underwent placement of an unspecified vena cava filter manufactured by cordis.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter perforation.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will suffer significant medical expenses, pain and suffering and other damages.According to the information received in the patient profile form (ppf), a cordis type inferior vena cava (ivc) filter was identified per scan imaging done.The type of filter was not identified, and the exact implant date is unknown.The additional information received included two images of an abdominal computerized tomography (ct) scan that appear to show an inferior vena cava filter; however, a radiology report was not provided.The patient reports perforation of filter struts outside the ivc, becoming aware of these events approximately sixteen years and seven months after the filter implantation, and further experienced anxiety related to the filter.According to the information received in the amended patient profile form (ppf), the patient additionally reports becoming aware of unknown bleeding, causing anemia, coldness and tiredness.
 
Manufacturer Narrative
As reported, a patient underwent placement of an unspecified cordis inferior vena cava (ivc) filter.The indication for filter insertion has not been provided.The filter malfunctioned including filter perforation.Per the patient profile form (ppf), the cordis filter was identified via imaging.Two images from a ct scan appear to show an inferior vena cava filter; however, a radiology report was not provided.The patient reports ivc perforation, unknown symptomatic bleeding, and anxiety related to the filter.The filter remains implanted thus unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The cordis vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after seventy-one days from implantation revealing some level of perforation.Bleeding is a known potential event associated to the use of ivc filters; however, in this case, the source of bleeding has not been identified therefore no relationship to the filter can be confirmed.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
 
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Brand Name
UNKNOWN VENA CAVA FILTER
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
MDR Report Key11671024
MDR Text Key247752601
Report Number9616099-2021-04413
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKFILTER
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN.
Patient Outcome(s) Life Threatening;
Patient Age62 YR
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