MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Fracture (1260)

Patient Problems Perforation (2001); Stenosis (2263); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

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, the patient underwent placement of the 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, specific evidence via computerized topography (ct) scan of abdomen that filter had fractured and perforated the vena cava wall, with one fractured strut folded just anterior to the lumbar spine and another limb minimally extending into the right psoas muscle.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.The instructions for use (ifu) states filter fracture with perforation 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.It was reported that there was perforation of the ivc and other structures; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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 team, 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, specific evidence via computerized topography (ct) scan of abdomen that filter had fractured and perforated the vena cava wall, with one fractured strut folded just anterior to the lumbar spine and another limb minimally extending into the right psoas muscle.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

Additional information was provided and is available in: section a2 (age at the time of event, date of birth) section b3 (event date) section b5 (event description) section b7 (relevant history race and medical history) section d11 (concomitant medical products and therapy dates) unknown microneedle unknown sheath unknown guidewire section g4 (date received by the manufacturer) section h6 (evaluation codes) the implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal team, 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, specific evidence via computerized topography (ct) scan of abdomen that filter had fractured and perforated the vena cava wall, with one fractured strut folded just anterior to the lumbar spine and another limb minimally extending into the right psoas muscle.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, 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 medical records: the filter was implanted after patient was admitted with venous thrombosis and a pulmonary emboli and severe leg swelling and leg pain.The filter was placed over the body of l3 a venogram showed the filter was in good position filling out the vena cava with no evidence of thrombus.Approximately 7 years, 1 month, post implantation, the filter was removed successfully using laser, forceps, and wire loop; fractured fragment removed with forceps.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 6 years, 8 months post implantation.The patient reports fracture, perforation of filter strut(s) outside the ivc, perforation of filter strut(s) into organs.The patient also reports suffering from dizziness, chest pains, depression, sharp pain sensations form abdomen, occasional bleeding, and anxiety.

Manufacturer Narrative

Complaint conclusion: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, at the time of filter implant, the patient was admitted with venous thrombosis and a pulmonary emboli and severe leg swelling and leg pain.The filter was placed over the body of l3, a venogram showed the filter was in good position filling out the vena cava with no evidence of thrombus.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter had fractured and perforated the vena cava wall, with one fractured strut folded just anterior to the lumbar spine and another limb minimally extending into the right psoas muscle per ct scan.Approximately 7 years, 1 month, post implantation, the filter was removed successfully using laser, forceps, and wire loop; fractured fragment removed with forceps.Per the patient profile form (ppf), the patient reports fracture, perforation of filter strut(s) outside the ivc, perforation of filter strut(s) into organs.The patient also reports suffering from dizziness, chest pains, depression, sharp pain sensations form abdomen, occasional bleeding, 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.The instructions for use (ifu) states filter fracture with perforation 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.It was reported that there was perforation of the ivc and surrounding structures; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Anxiety, dizziness, depression, bleeding and chest pain do not represent device malfunctions 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

The catalog number is unkown; if received, it will be provided.Complaint conclusion: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, at the time of filter implant, the patient was admitted with venous thrombosis and a pulmonary emboli and severe leg swelling and leg pain.The filter was implanted after patient was admitted with venous thrombosis and a pulmonary emboli and severe leg swelling and leg pain.The filter was placed over the body of l3 a venogram showed the filter was in good position filling out the vena cava with no evidence of thrombus.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, specific evidence via ct scan that filter had fractured and perforated the vena cava wall, with one fractured strut folded just anterior to the lumbar spine and another limb minimally extending into the right psoas muscle.Approximately 7 years, 1 month, post implant, the filter was removed successfully using laser, forceps, and wire loop; fractured fragment removed with forceps.Balloon angioplasty was also done at this time to correct ivc stenosis.Per the patient profile form (ppf), the patient reports fracture, perforation of filter strut(s) outside the inferior vena cava (ivc), perforation of filter strut(s) into organs.The patient also reports suffering from dizziness, chest pains, depression, sharp pain sensations form abdomen, occasional bleeding, 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.The instructions for use (ifu) states filter fracture with perforation 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.It was reported that there was perforation of the ivc and surrounding structures; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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.Anxiety, dizziness, depression, bleeding and pain (chest and abdominal) 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 team, 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, specific evidence via computerized topography (ct) scan of abdomen that filter had fractured and perforated the vena cava wall, with one fractured strut folded just anterior to the lumbar spine and another limb minimally extending into the right psoas muscle.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, 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 medical records: at the time of filter implant, the patient was admitted with venous thrombosis and a pulmonary emboli and severe leg swelling and leg pain.The filter was implanted after patient was admitted with venous thrombosis and a pulmonary emboli and severe leg swelling and leg pain.The filter was placed over the body of l3 a venogram showed the filter was in good position filling out the vena cava with no evidence of thrombus.The patient tolerated the procedure well.Approximately 7 years, 1 month, post implantation, the filter was removed successfully using laser, forceps, and wire loop; fractured fragment removed with forceps.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 6 years, 8 months post implantation.The patient reports fracture, perforation of filter strut(s) outside the inferior vena cava (ivc), perforation of filter strut(s) into organs.The patient also reports suffering from dizziness, chest pains, depression, sharp pain sensations form abdomen, occasional bleeding, and anxiety.According to the discovery form, the patient received the ivc filter for deep vein thrombosis (dvt) and pulmonary embolism (pe).Medical conditions and treatments alleged to be attributable to the implanted ivc filter include chest pain, filter perforating the ivc with one fractured strut for which the patient experienced sharp pain in the rib cage, in addition to complex ivc filter removal and balloon angioplasty procedure to correct stenosis.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8057682
• MDR Text Key: 126901967
• Report Number: 1016427-2018-02235
• 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: other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• 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: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR