MAUDE Adverse Event Report: CORDIS CORPORATION UNSPECIFIED CORDIS VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKFILTER

Device Problem Unintended Movement (3026)

Patient Problems Perforation (2001); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/18/2019

Event Type  Death  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of an unknown vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforation, tilt and embedment.The information also indicated that the patient was deceased, but not cause of death or relationship to the unknown filter was provided.The indication for the filter implant, implant report and medical records have not been provided.There is currently no additional information available for review.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.Cordis 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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Without images or procedural films for review, the reported filter tilt and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with operator technique and/or vessel anatomy, specifically asymmetry and tortuousness.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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.Without procedural films or post implant imaging available for review the reported events could not be confirmed or further clarified.It was reported that the patient is deceased; however, with the limited information provided, a relationship between the device and the event could not be established.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.(b)(4).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 unspecified cordis vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter perforation, tilt 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, pain and suffering, and other damages.The patient is deceased, but there was no indication if this was related to the device.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

Event Description

Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), filter tilt and embedment.The patient became aware of the reported events approximately eight years and nine months after the index procedure.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g3, g6, h1, h2 and h6.It was reported that a patient underwent placement of an unknown vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforation, tilt and embedment.The information also indicated that the patient was deceased, but not cause of death or relationship to the unknown filter was provided.Additional information received from the patient representative, indicated that there was perforation of filter strut(s) outside the inferior vena cava (ivc), filter tilt and embedment.The representative became aware of the reported events approximately eight years and nine months post implant.The indication for the filter implant, implant report and medical records have not been provided.There is currently no additional information available for review.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.Cordis 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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Without images or procedural films for review, the reported filter tilt and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with operator technique and/or vessel anatomy, specifically asymmetry and tortuousness.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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.Without procedural films or post implant imaging available for review the reported events could not be confirmed or further clarified.It was reported that the patient is deceased; however, with the limited information provided, a relationship between the device and the event could not be established.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: UNSPECIFIED CORDIS VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11396368
• MDR Text Key: 234200672
• Report Number: 9616099-2021-04307
• Device Sequence Number: 1
• Product Code: DTK
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR