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

Catalog Number UNKFILTER

Device Problem Unintended Movement (3026)

Patient Problems Myocardial Infarction (1969); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263)

Event Date 08/28/2020

Event Type  Injury  

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 stenosis, perforation and tilting.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.Without procedural films for review, the reported events could not be confirmed or further clarified.Stenosis is an abnormal narrowing in a blood vessel and does not represent a device malfunction.Ivc filter tilt has been associated with practitioner technique and/or the anatomy of the vessel, specifically asymmetry and tortuosity.The ifu notes vessel damage such as intimal tears and perforation as a long-term and procedural complication related to ivc filters.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.

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 stenosis, perforation and tilting.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, the patient underwent placement of an unspecified cordis vena cava filter.The indication for the filter placement was not reported.More than fifteen years after the filter implantation, the patient became aware that the filter had tilted, that filter struts had perforated outside the inferior vena cava (ivc) and was associated stenosis.The unspecified cordis vena cava filter was reported to have been identified during diagnostic imaging.The patient further reported having experienced anxiety, back pain, a heart attack and an inability to control their diabetes associated with the filter.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 is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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 and ivc perforation events 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.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural 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.Due to the nature of the complaint, the reported pain and myocardial infarction experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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, mental anguish, fear, 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.

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 stenosis, perforation and tilting.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 filter was identified per scan imaging done.The type of filter was not identified, and the exact implant date is unknown.The patient reports perforation of filter struts outside the ivc and tilting of the filter, becoming aware of these events approximately fifteen years and seven months after the filter implantation.The patient further asserts to have suffered from a heart attack and back pain post implant and experienced anxiety related to the filter which affects the patient¿s ability to control diabetes.

• 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 Key: 12169578
• MDR Text Key: 261700153
• Report Number: 9616099-2021-04710
• 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
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening