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

Catalog Number UNKFILTER

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 09/08/2021

Event Type  Injury  

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.Implant date is approximately october 2005.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 organ perforation.The indication for the filter placement and pertinent 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.An inferior vena cava filter is 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.The ifu notes vessel damage such as intimal tears and perforation as a long-term and procedural complication related to ivc filters.Complete perforation of the ivc wall by the filter struts may impact abutting organs.Without post-placement imaging and the limited information provided, the report of organ perforation could not be confirmed or further clarified, nor a relationship between the device and the event be drawn.Given the limited information currently available for review, 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.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an unknown 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 organ perforation.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.

Event Description

According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the inferior vena cava (ivc) and perforation into organs, becoming aware of these events approximately fifteen years and eleven months after the filter implantation.The patient further experienced stress, anxiety, chest pain and insomnia related to the filter.Neither the type of cordis ivc filter that was implanted nor procedural details were provided.

Manufacturer Narrative

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 organ perforation.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava (ivc) and into organs, approximately fifteen years and eleven months post implant.The patient also reported stress, anxiety, chest pain and insomnia related to the filter.The indication for the filter placement and pertinent 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.An inferior vena cava filter is 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.The ifu notes vessel damage such as intimal tears and perforation as a long-term and procedural complication related to ivc filters.Complete perforation of the ivc wall by the filter struts may impact abutting organs.Without post-placement imaging and the limited information provided, the report of organ perforation could not be confirmed or further clarified, nor a relationship between the device and the event be drawn.Anxiety and associated symptoms such as insomnia and chest pain do not represent a device malfunction and may be related to underlying patient specific issues and undisclosed comorbidities.Given the limited information currently available for review, 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.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15315922
• MDR Text Key: 298859944
• Report Number: 9616099-2022-05930
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female