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

Model Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528); Unintended Movement (3026); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Stenosis (2263)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown; if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt, fracture, ivc occlusion, pain at the filter location, as well as stenosis of the ivc requiring a complicated initial removal procedure followed by a second complicated procedure to remove fragments of the filter that had fractured and migrated to other portions of the body.The patient suffered from and will continue to suffer from severe pain and edema due to stenosis of the ivc.The filter is 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 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 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.Inferior vena cava (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 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 for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.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.Pain does 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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt, fracture, ivc occlusion, pain at the filter location, as well as stenosis of the ivc requiring a complicated initial removal procedure followed by a second complicated procedure to remove fragments of the filter that had fractured and migrated to other portions of the body.The patient suffered from and will continue to suffer from severe pain and edema due to stenosis of the ivc.

Event Description

Additional information received per the medical records indicate that the patient has a history of colon cancer, partial aphasia, benign prostatic hyperplasia (bph), bilateral pulmonary embolism (pe), hypertension, hypercholesterolemia, pre-diabetes, hematuria, obesity, osteoarthritis (right knee) and left total knee replacement, thromboembolism bilateral femoral veins and right shoulder acromioclavicular (ac) separation.  approximately eleven years and eight months after the index procedure the patient presented with syncopal episode, thrombosed inferior vena cava (ivc), thrombosed filter, pulmonary embolism and bilateral deep vein thrombosis (dvt).Thrombolytics was initiated, followed by ekosonic endovascular system (ekos) mechanical thrombectomy with v-fib arrest during thrombectomy.The patient was discharged after approximately two weeks.Approximately two weeks after discharge, the patient experienced atypical chest pain and no evidence of new pe.There were plans for potential ivc filter removal.Approximately eleven years and nine months after the index procedure the patient experienced lightheaded / dizziness, possible filter strut embolization and recurrent pulmonary emboli was noted.Chronic dvt in left leg was noted on imaging.During this same month the patient had a complex removal of the ivc filter.At the time of removal, it was noted that the filter was intact.Approximately eleven years and eleven months after the index procedure the patient received surgical clearance for right total knee replacement, stress test, cardiac catheterization cleared for surgery with elequis bridge for anticoagulation.Later that same month the patient had right leg total knee replacement.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g3, g6, h1, h2 and h6.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes colon cancer, partial aphasia, benign prostatic hyperplasia (bph), bilateral pulmonary embolism (pe), hypertension, hypercholesterolemia, pre-diabetes, hematuria, obesity, osteoarthritis (right knee) and left total knee replacement, thromboembolism of bilateral femoral veins (dvt) and right shoulder acromioclavicular (ac) separation.The filter subsequently malfunctioned including tilt, fracture, ivc occlusion, edema, pain at the filter location, stenosis of the ivc, migration of the filter, and a complicated filter removal with a second follow-up retrieval.Approximately eleven years and eight months post implant, the patient had a syncopal episode, as well as a thrombosed ivc and filter, pulmonary embolism and bilateral dvt.Thrombolytics were initiated, followed by ekos mechanical thrombectomy, complicated by v-fib arrest.The patient was discharged approximately two weeks later.Approximately two weeks after discharge, the patient experienced atypical chest pain with no evidence of new pe.Approximately eleven years and nine months post implant, the patient was lightheaded / dizzy, and diagnosed with possible filter strut embolization and recurrent pulmonary emboli was noted.Chronic dvt in left leg was noted on imaging.During this same month the patient had a complex removal of the ivc filter.At the time of removal, it was noted that the filter was intact.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 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.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.Inferior vena cava (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 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 for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Pain does 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 TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10204508
• MDR Text Key: 196854279
• Report Number: 1016427-2020-04094
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/28/2020
• Supplement Dates Manufacturer Received: 02/04/2021; 03/02/2021
• Supplement Dates FDA Received: 03/01/2021; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR