MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 46XXXXX

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); Cardiac Perforation (2513)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.As reported, the patient underwent placement of an unknown vena cava filter.The indication for the filter placement was not reported.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter, perforation of the inferior vena cava wall, aortic perforation and embedment.As a direct and proximate result of these malfunctions, 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 continue to suffer significant medical expenses, and pain and suffering, and other damages.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.Vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The patient is also reported to have had perforations of the ivc and of the aorta.However, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.It was further reported that the patient¿s filter was embedded.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as twelve days.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an unknown vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter, perforation of the inferior vena cava wall, aortic perforation and embedment.As a direct and proximate result of these malfunctions, 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 continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received.Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis while on anticoagulation therapy.The filter was deployed via the right common femoral vein.It was placed at the l3 level below the renal veins.The placement procedure was uneventful.Additional information received per the patient profile form (ppf) states that nine years and eight months after the index procedure, computed tomography (ct) scans indicated tilting of the filter, perforation of the filter struts outside the inferior vena cava and embedment of the filter in the inferior vena cava wall.The patient also experienced pain, suffering, anxiety and emotional distress.As reported, the patient underwent placement of an unknown vena cava filter.Additional information received indicated that the patient had a history of deep vein thrombosis (dvt) while on anticoagulation therapy.The filter was deployed via the right common femoral vein.It was placed at the l3 level below the renal veins.The placement procedure was uneventful.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter, perforation of the inferior vena cava (ivc) wall, aortic perforation and embedment.As a direct and proximate result of these malfunctions, 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 continue to suffer significant medical expenses, and pain and suffering, and other damages.Nine years and eight months after the index procedure, computed tomography (ct) scans indicated tilting of the filter, perforation of the filter struts outside the ivc and embedment of the filter in the ivc wall.The patient also experienced pain, suffering, anxiety and emotional distress.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.Vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The patient is also reported to have had perforations of the ivc and of the aorta.However, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.It was further reported that the patient¿s filter was embedded.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as twelve days.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8134628
• MDR Text Key: 129376245
• Report Number: 9616099-2018-02571
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46XXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 02/05/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 4-FRENCH CANULA; UNKNOWN 5-FRENCH PIGTAIL CATHETER
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 69 YR