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

Model Number N/A

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problems Perforation (2001); Embolism/Embolus (4438)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available.Patient age and medical history were also not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter tilt with the apex against the ivc wall, there was a 4mm small bowel, 4mm vertebral and 5mm mesenteric perforation and a fractured strut.The indication for the filter implant has not been provided and 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.The trapease ivc 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 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.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also 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 timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported filter tilt, fracture and organ perforation could not be confirmed or further clarified.There is nothing to suggest that the reported event is related to the design and/or 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 in the legal brief, the patient was treated with a trapease vena cava filter but the filter subsequently malfunctioned and caused injury, damage, including, but not limited to there is specific evidence that the filter was tilted with the apex against the ivc wall, there was a 4mm small bowel, 4mm vertebral and 5mm mesenteric perforation and a fractured strut.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, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: a2, b5, g3, h1, h2, h3 and h6 new codes of anxiety, pe, previous codes of tilt, perforation and fracture it was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter tilt with the apex against the ivc wall, there was a 4mm small bowel, 4mm vertebral and 5mm mesenteric perforation and a fractured strut.The patient reported becoming aware of filter fracture, perforation of filter struts outside the inferior vena cava (ivc) and into organs (4mm small bowel, 4mm vertebral and 5mm mesenteric), and tilt, approximately seventeen years post implant.The patient also reported 2 post implant pulmonary emboli, approximately eighteen years post implant and anxiety related to the filter.Per the medical records the patient had a history of thyroid disease, chronic pancreatitis, antiphospholipid syndrome, multiple deep vein thrombosis (dvt), lupus, heart failure, nonobstructive coronary artery disease, depression, chronic obstructive pulmonary disease (copd), diabetes, hypertension, hyperlipidemia, migraines, gerd, obesity, tobacco abuse.The patient had a computed tomography (ct) scan performed approximately 17 years post implant, the report was reviewed again approximately eight months later and focused solely on the filter.The report noted tilting with the apex against the wall, 4mm small bowel, vertebral and 5mm mesenteric perforation and a fractured strut.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 trapease ivc 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 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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also 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 timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or 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 in the legal brief, the patient was treated with a trapease vena cava filter but the filter subsequently malfunctioned and caused injury, damage, including, but not limited to there is specific evidence that the filter was tilted with the apex against the ivc wall, there was a 4mm small bowel, 4mm vertebral and 5mm mesenteric perforation and a fractured strut.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, and pain and suffering, and other damages.According to the patient profile form: the patient reported becoming aware of filter fracture, perforation of filter struts outside the inferior vena cava (ivc) and into organs (4mm small bowel, 4mm vertebral and 5mm mesenteric), and tilt, approximately seventeen years post implant.The patient also reported 2 post implant pulmonary emboli and anxiety related to the filter.Per the medical records the patient had a history of thyroid disease, chronic pancreatitis, antiphospholipid syndrome, multiple deep vein thrombosis (dvt), lupus, heart failure, nonobstructive coronary artery disease, depression, chronic obstructive pulmonary disease (copd), diabetes, hypertension, hyperlipidemia, migraines, gerd, obesity, tobacco abuse.Approximately 8 years post implant, the patient had hip and pelvis x-ray which was performed for left hip and pelvis pain, results noted osteoarthritis of the right hip.Approximately 9 years the patient presented to the er with complaints of abdominal pain.Abdominal x-rays showed moderate stool throughout the colon, an ivc filter and no evidence of obstruction.Approximately 11 years post implant, an an abdominal ct scan was performed for right lower quadrant pain.Results of the scan noted opacified proximal ileal loops likely due to enteritis.A 3mm non obstructing right kidney stone was also observed.Approximately 12 years after, a computed tomography (ct) scan was performed for hematuria with right upper quadrant pain, nausea, history of renal calculi and pancreatitis.The findings noted a non-obstructing right renal calculus and there is a cordis ivc filter in place.An additional computed tomography (ct) scan was performed for hematuria with right upper quadrant pain, nausea, history of renal calculi and pancreatitis.The findings noted a non-obstructing right renal calculus and there is a cordis ivc filter in place.Approximately 14 years post implant, the patient was seen after presenting to the hospital for chest pain and shortness of breath.Approximately 15 years post implant, the patient presented to the emergency room (er) with abdominal pain, nausea, and vomiting.The patient had a ct approximately 17 years post implant, the report was reviewed and focused solely on the filter.The report noted tilting with the apex against the wall, 4mm small bowel and vertebral and 5mm mesenteric perforation and a fractured strut.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12217694
• MDR Text Key: 263150193
• Report Number: 1016427-2021-05115
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Congenital Anomaly; Required Intervention; Other
• Patient Age: 50 YR
• Patient Sex: Female