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

Catalog Number UNKFILTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263); Thrombosis/Thrombus (4440)

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 and caused injury and damage to the patient, including, but not limited to filter perforation, ivc stenosis and caval thrombosis.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.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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, inferior vena cava (ivc) stenosis and caval thrombosis.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.

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, inferior vena cava (ivc) stenosis and caval thrombosis.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.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, stenosis and caval thrombosis, becoming aware of these events approximately fifteen years and seven months after the filter implantation.The patient further asserts to have suffered from blood in the urine and blood clots post implant, and experienced anxiety related to the filter.

Manufacturer Narrative

As reported, a patient had placement an unknown cordis inferior vena cava (ivc).The indication for filter insertion has not been provided.The filter subsequently malfunctioned including perforation, ivc stenosis and thrombosis.Per the patient profile form (ppf), a ct scan identified a cordis filter.The patient reports perforation of filter struts outside the ivc, stenosis and caval thrombosis, blood in the urine and blood clots post implant, and anxiety related to the filter.Two images from a ct scan show an ivc filter that appears to be a cordis design; however, a radiology interpretation was not provided.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Anxiety and blood in the urine do 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.

• 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: 11665796
• MDR Text Key: 245937732
• Report Number: 9616099-2021-04409
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR