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

Catalog Number 466F220A

Device Problems Failure to Align (2522); Unintended Movement (3026); Migration (4003)

Patient Problems Abdominal Pain (1685); Pain (1994); Injury (2348)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had been malpositioned in the inferior vena cava (ivc) and had migrated.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 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 migration and filter malposition could not be confirmed and the exact cause could not be determined.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (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 ivc 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.According to the ifu, incorrect positioning is a possible procedural complication related to ivc filters.In addition, the use of ivc filters is contraindicated in patients with an ivc diameter of larger than 30mm.If strong resistance is met during any stage of the procedure, users are to discontinue the procedure and determine the cause before proceeding.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.Please note that this is the initial/final 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 migration and malposition of the filter in the inferior vena cava (ivc).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

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused migration and malposition of the filter in the inferior vena cava (ivc).The patient reported becoming aware of migration of fractured struts, and filter tilting approximately nine years and ten months post implant.The patient also reports chest pain and tightness post implant, shortness of breath, increased asthma symptoms, coughing, chronic bilateral lower extremity edema with discoloring and pain, insomnia, increased anxiety and mental anguish in addition to fear of having a removal surgery as the patient has been told it would require a more serious open surgery.According to the implant record the indication for the filter implant was deep vein thrombosis (dvt) and massive bilateral pulmonary embolus (pe).The filter was placed via the right internal jugular vein and deployed in the infrarenal ivc.The patient tolerated the procedure well.Approximately seven years and eight months post implant, the patient underwent an abdominal computerized tomography (ct) scan indicated for abdominal pain.The ct scan reported a cordis filter with tilting and migration.Neither fracture, perforation nor stenosis was reported.The patient history is noted for obesity, diabetes, kidney disease, asthma, chronic obstructive pulmonary disease, cellulitis and gout of the right foot, sleep apnea and post-traumatic stress disorder.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The optease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the 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 migration, tilt and malposition could not be confirmed, nor an exact cause be determined.Ivc filter tilt has been associated with practitioner technique, the anatomy of the vessel, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated ivc filters and is listed in the ifu as such.Possible causes for 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.According to the ifu, incorrect positioning is a possible procedural complication related to ivc filters.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.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, 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 migration and malposition of the filter in the inferior vena cava (ivc).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.Although the legal brief reported the patient was implanted with a cordis trapease filter, the operative report indicates the patient received an optease filter.Per the implant records, the patient was reported to have a history of bilateral pulmonary embolism (pe).The filter was implanted due to deep vein thrombosis (dvt).A cordis optease retrieval filter was placed via the right internal jugular in an infrarenal location.The patient tolerated the procedure well.Approximately seven years and eight months after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan indicated for abdominal pain.The ct scan reported a cordis filter with tilting and migration.Neither fracture, perforation nor stenosis was reported.Approximately two years later, the patient had an office follow up visit with the primary care physician for pain medication due to chronic pain.The patient was noted to have right sided abdominal pain due to multiple abscesses on the abdomen, as well as left hip, knee and neck (arthralgia) pain.The record noted that the patient had been hospitalized six times post filter placement for cellulitis, kidney stones, and infection of the right leg.The patient history is noted for obesity, diabetes, kidney disease, asthma, chronic obstructive pulmonary disease, cellulitis and gout of the right foot, sleep apnea and post-traumatic stress disorder.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately nine years and ten months after the filter implantation.The patient reports migration of fractured struts, filter tilting and lifelong anticoagulation.The patient further asserts to have suffered from intermittent chest pain and tightness post implant, shortness of breath, increased asthma symptoms, coughing, chronic bilateral lower extremity edema with discoloring and pain, insomnia, increased anxiety and mental anguish in addition to fear of having removal surgery as the patient has been told it would require a more serious open surgery.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10295149
• MDR Text Key: 199704904
• Report Number: 1016427-2020-04221
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R1108035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR
• Patient Weight: 148