MAUDE Adverse Event Report: UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problems Fracture (1260); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, senior counsel, litigation.As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation and tilting of the filter.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 tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The brief also reported a perforation.However, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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 perforation and tilting of the filter.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of morbid obesity, right leg deep vein thrombosis.The filter was placed prophylactically for pulmonary thromboembolism.The filter was deployed via the right internal jugular vein.It was placed at the l2-l3 level, midway between the renal veins and iliac bifurcation.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava and tilting of the filter.The patient became aware of the reported events eight years after the index procedure.The patient continues to experience aches/cramping type twinges in her chest.The patient also feels the filter moving when she bends over and stands up.The patient also states that her chest feels cold during cold weather.  additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter malfunctioned and caused injury and damage to the patient including, but not limited to perforation and tilting of the filter.The patient has also reported to experience aches/cramping type twinges in her chest.And that they feel the filter moving when bending over and standing up.The patient also reports that their chest feels cold during cold weather.The indication for the filter implant was prophylactically for pulmonary thromboembolism during an unspecified perioperative phase.The patient has a history of morbid obesity and a right leg deep vein thrombosis.The filter was placed via the right internal jugular vein and deployed at the level of l2-l3, midway between the renal veins and the iliac bifurcation.The patient became aware of the reported events eight years after the index procedure.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 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.Without images or procedural films for review, the reported filter tilt, migration and perforation could not be confirmed, and the exact causes could not be determined.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.The timing and mechanism of the tilt has not been reported at this time.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.Perforation was also reported; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or images for review the reported event(s) could not be confirmed.Due to the nature of the complaint, the reported feeling cold and aches in the chest could not be confirmed and the exact cause could not be determined, these events do not represent a device malfunction.There is nothing in the limited information available for review 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, b6, g3, g6, h1, h2 and h6.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter malfunctioned and caused injury and damage to the patient including, but not limited to perforation and tilting of the filter.The patient has also reported to experience aches/cramping type twinges in her chest.And that they feel the filter moving when bending over and standing up.The patient also reports that their chest feels cold during cold weather.The indication for the filter implant was prophylactically for pulmonary thromboembolism during an unspecified perioperative phase.The patient has a history of morbid obesity and a right leg deep vein thrombosis.The filter was placed via the right internal jugular vein and deployed at the level of l2-l3, midway between the renal veins and the iliac bifurcation.The patient became aware of the reported events eight years after the index procedure.New information provided by the patient indicated that the patient also became filter fracture approximately eleven years and three months post implant.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.Without images or procedural films for review, the reported filter tilt, migration and perforation could not be confirmed, and the exact causes could not be determined.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.The timing and mechanism of the tilt has not been reported at this time.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.Perforation was also reported; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also 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.Without procedural films or images for review the reported event(s) could not be confirmed.Due to the nature of the complaint, the reported feeling cold and aches in the chest could not be confirmed and the exact cause could not be determined, these events do not represent a device malfunction.There is nothing in the limited information available for review 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

Information received per an amended patient profile form (ppf) states that in addition to the previously reported events, the patient also experienced filter fracture.The patient became aware of the reported event approximately eleven years and three months after the index procedure.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 8103418
• MDR Text Key: 128329922
• Report Number: 1016427-2018-02303
• Device Sequence Number: 1
• Product Code: DQO
• 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,Followup
• Report Date: 10/06/2021

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 12/03/2018; 01/05/2019; 09/24/2021
• Supplement Dates FDA Received: 01/02/2019; 02/05/2019; 10/06/2021
• 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