MAUDE Adverse Event Report: 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572); Device Embedded In Tissue or Plaque (3165)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported by the legal department, the patient underwent placement of the trapease vena cava 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, pain, circulatory issues, and filter migration.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.The filter remains implanted; thus, 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 includes 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.Circulatory insufficiency and pain do 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, pain, circulatory issues, and filter migration.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

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

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, pain, circulatory issues, and filter migration.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.The following additional information was received per the patient¿s implant records: the filter was implanted over the base of the l3 level due to pulmonary embolus with free-floating right popliteal vein clot.The patient experienced onset of watery diarrhea after multiple antibiotic usage in a diabetic with documented elevated hemoglobin a1c.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately six years and two months post implantation.The patient reports experiencing tilt, filter embedded in wall of the ivc, and device unable to be retrieved; however, a retrieval attempt has not been made.The patient also reports suffering from pain, swelling, weakness, gi issues, and anxiety.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.Per the patient¿s implant records, the filter was implanted over the base of the l3 level due to pulmonary embolus with free-floating right popliteal vein clot.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, pain, circulatory issues, and filter migration.The patient reports experiencing tilt, filter embedded in wall of the ivc, and device unable to be retrieved; however, a retrieval attempt has not been made.The patient also reports suffering from pain, swelling, weakness, gi issues with watery diarrhea, and anxiety.The filter remains implanted; thus, 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.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.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 includes 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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Circulatory insufficiency, swelling, pain, weakness and gi upset do not represent a device malfunction and may be related to underlying patient related issues.Anxiety 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.

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 pain, circulatory issues, and filter migration.The patient reported becoming aware of experiencing tilt, filter embedded in wall of the ivc, and device unable to be retrieved approximately six years and two months post implant.The patient indicated that no retrieval attempt had been made.The patient also reported experiencing pain, swelling, weakness, gastrointestinal issues and anxiety.The patient subsequently reported becoming aware of perforation of filter strut(s) outside the ivc abutting an adjacent organ.According to the implant record the indication for the filter implant was bilateral pulmonary embolus and free-floating clot in the right popliteal vein.The filter was placed via the right popliteal vein and deployed over the base of the l3 vertebrae level.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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Circulatory insufficiency, swelling, pain, weakness, anxiety and gi upset do 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.

Manufacturer Narrative

As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.Per the medical records, the indication for filter was bilateral pulmonary emboli (pe) and a free-floating thrombus in the right popliteal vein.History includes diaphragmatic paralysis secondary to abdominal surgery, multiple small bowel obstructions, cervical spinal fusion with hardware, asthma, obstructive sleep apnea, congestive heart failure, osteoarthritis of the knee, hypertension and type 2 diabetes mellitus.A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.The filter malfunctioned including circulatory issues and filter migration.Four days after implant, the patient was seen for abdominal pain, and a partial small bowel obstruction was noted; two months later was seen again for abdominal pain.Imaging did not reveal any acute intestinal processes.The chest x-ray revealed atelectasis on the left side, with possible pneumonia.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc abutting an adjacent organ, and migration of entire filter other than to heart, circulatory insufficiency, weakness and anxiety.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 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.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.Anxiety, circulatory insufficiency, and weakness do 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including but not limited to pain, circulatory issues, and filter migration.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.Per the medical records, prior to the index procedure the patient was admitted to the hospital with progressive shortness of breath and a past medical history significant for diaphragmatic paralysis secondary to abdominal surgery, obstructive sleep apnea, hypertension and type 2 diabetes mellitus.Per the operative report, the patient was reported to have presented with chest pain and was found to have bilateral pulmonary emboli (pe) and a free-floating thrombus in the right popliteal vein.Using ultrasound guidance, the patient underwent placement of the inferior vena cava (ivc) filter and removal of the right popliteal vein clot.The indication for filter placement was deep vein thrombosis (dvt).A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.The medical history at the time included multiple small bowel obstructions with surgical resections, cervical spine fusion with hardware insertion, asthma, obstructive sleep apnea and diabetes.The patient was noted to be negative for factor v leiden mutation and a limited community ambulator secondary to osteoarthritis with swelling of the knee, significant shortness of breath and chest congestion secondary to pneumonia and asthma, and was established on an oral anticoagulation regimen.Four days after the filter was implanted, the patient was seen for abdominal pain, and a partial small bowel obstruction was noted; two months later was seen again for abdominal pain.Imaging did not reveal any acute intestinal processes.The chest x-ray revealed atelectasis on the left side, with possible pneumonia.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately six years and two months post implantation.The patient reports experiencing tilting of the filter, filter embedded in wall of the ivc, and device unable to be retrieved; however, a retrieval attempt has not been made.The patient also reports suffering from pain, swelling, weakness, gastrointestinal (gi) issues and anxiety.According to the information received in the amended ppf, the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to perforation of filter strut(s) outside the ivc abutting an adjacent organ and migration of entire filter other than to heart.The patient also reports anxiety.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 7433445
• MDR Text Key: 105597288
• Report Number: 1016427-2018-01384
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 0.035 WIRE; 18-GAUGE NEEDLE; 18-GAUGE NEEDLE, 0.035 WIRE; UNK 0.035 WIRE; UNK 18-GAUGE NEEDLE
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Weight: 94