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

Catalog Number UNKFILTER

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Perforation of Vessels (2135)

Event Date 05/07/2019

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.It was reported that a patient underwent placement of an unspecified cordis vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused pulmonary embolism.The patient reported becoming aware of the event approximately sixteen years post implant.The patient also reports back pain related to the filter.A radiographic image provided depicts an unspecified cordis type filter.There is no other information available.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Pulmonary embolism does not represent a device malfunction, rather clinical factors that may have influenced the events include patient and or pharmacological.With the limited information provided a clinical determination could not be made regarding the event.Given the 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 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 pulmonary embolism.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.Additional information received per the patient profile form (ppf) states that the patient experienced pulmonary embolism.The patient became aware of the reported events approximately seventeen or eighteen years after the index procedure.The patient continues to experience back pain.An imaging scan was made available.The form states that the image is an unspecified cordis filter.

Manufacturer Narrative

It was reported that a patient underwent placement of an unspecified cordis vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused pulmonary embolism.The patient reported becoming aware of the event approximately sixteen years post implant.The patient also reports back pain related to the filter.A radiographic image provided depicts an unspecified cordis type filter.The patient subsequently reported becoming aware of filter fracture within the inferior vena cava (ivc), ivc perforation and filter tilt, approximately seventeen- or eighteen-years post implant.It was also reported that the device was unable to be retrieved, however no documentation of removal attempts was provided.The patient continues to experience back pain.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Pulmonary embolism does not represent a device malfunction, rather clinical factors that may have influenced the events include patient and or pharmacological.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.The ifu notes vessel damage such as intimal tears and perforation as a long-term and procedural complication related to ivc filters.Without images available for review the reported events could not be confirmed or further clarified.Back pain does not represent a device malfunction and may be related to underlying patient specific issues.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

Additional information received per an amended patient profile form (ppf) states that the patient experienced pulmonary embolism, filter fracture within the inferior vena cava (ivc), ivc perforation and filter tilt.The form states that the device was unable to be retrieved, but no documentation of any attempt to remove the device was provided the patient became aware of the reported events approximately seventeen or eighteen years after the index procedure.The patient continues to experience back pain.

• 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: 11703875
• MDR Text Key: 259681809
• Report Number: 9616099-2021-04450
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2022
• 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: 62 YR
• Patient Sex: Female