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

Catalog Number 466P306X

Device Problems Fracture (1260); Unintended Movement (3026); Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Date of event: 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 a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused anterior tilt of the filter measuring 8.44 degrees; right-sided tilt measuring 10.43 degrees; migration of the inferior apex of the caval filter which extends to the bifurcation; and 6 o'clock and 4 o'clock fractured struts.The indication for the filter implant, procedural details and medical history of the patient 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.The trapease 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 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.The instructions for use (ifu) states 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.Ivc filter tilt has been associated operator technique and/or vessel anatomy, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Without procedural films or post implant images for review the reported event(s) could not be confirmed or further clarified.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.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to anterior tilt of the filter measuring 8.44 degrees; right-sided tilt measuring 10.43 degrees; migration of the inferior apex of the caval filter which extends to the bifurcation; and 6 o'clock and 4 o'clock fractured struts.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.

Manufacturer Narrative

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 anterior tilt of the filter measuring 8.44 degrees; right-sided tilt measuring 10.43 degrees; migration of the inferior apex of the caval filter which extends to the bifurcation; and 6 o'clock and 4 o'clock fractured struts.The patient reported becoming aware of filter fracture and tilt approximately fourteen years and five months post implant.The patient also reported experiencing shortness of breath, chest and abdominal pain, heart palpitations, depression and infections related to the filter.According to the medical records the indication for the filter placement was iliac deep vein thrombosis (dvt) and a history of pulmonary emboli (pe).The filter was implanted via the patient's right internal jugular vein and deployed between the bifurcation and the renal takeoff.Completion venogram showed the device to be in excellent position and fully expanded.A computed tomography (ct) scan was performed approximately fourteen years and five months post implant to evaluate the filter.The films were submitted for additional interpretation.The dictation provided refers only to the filter.A cordis type filter is depicted in the images.The reader noted no perforation of the filter, the filter was tilted and there was migration of the filter with the inferior apex of the filter extending to the bifurcation.Also noted were fractured struts at 4 o¿clock and 6 o¿clock.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 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 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.The instructions for use (ifu) states 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.Ivc filter tilt has been associated operator technique and/or vessel anatomy, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Without procedural films or post implant images for review the reported event(s) could not be confirmed or further clarified.Due to the nature of the complaint the reported shortness of breath, pain (chest and abdominal), heart palpitations, depression and infections could not be further clarified.These events do not represent a device malfunction and may be related to underlying patient specific issues.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

Additional information received per the medical records indicate that the indication for the filter implant was iliac deep vein thrombosis (dvt) and a history of pulmonary emboli (pe).The filter was implanted via the patient's right internal jugular vein.It was deployed between the bifurcation and the renal takeoff.Completion venogram showed the device to be in excellent position and fully expanded.A computed tomography (ct) scan was performed approximately fourteen years and five months after the index procedure to evaluate the filter.The films were submitted for additional interpretation.The dictation provided refers only to the filter.A cordis type filter is depicted in the images.The reader noted no perforation of the filter, the filter was tilted and there was migration of the filter with the inferior apex of the filter extending to the bifurcation.Also noted were fractured struts at 4 o¿clock and 6 o¿clock.Additional information received per the patient profile form (ppf) states that the patient experienced fracture and tilt.The patient became aware of the reported events approximately fourteen years and five months after the index procedure.The patient also reported experiencing shortness of breath, chest and abdominal pain, heart palpitations, depression and infections related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• 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: 13043392
• MDR Text Key: 282547846
• Report Number: 9616099-2021-05204
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• 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: 59 YR
• Patient Sex: Female