MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

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

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Perforation (2001)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease vena cava filter on or about (b)(6) 2005.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, perforation of the inferior vena cava (ivc), migration, and subsequent pulmonary embolism (pe).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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.  the trapease 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 cause could not be determined.The timing and mechanism of the reported filter tilt is unknown.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 it ivc filters.Inferior vena cava (ivc) filter migration is also 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 brief also mentioned pulmonary embolism.As stated above, this cannot be confirmed without films available for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Implant date: on or about (b)(6) 2005.

Event Description

As reported by the legal brief, the patient underwent placement of the defendants' trapease vena cava filter on or about (b)(6) 2005.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, perforation of the inferior vena cava (ivc), migration, and subsequent pulmonary embolism (pe).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

After further review of additional information received, the following sections have been updated accordingly.Addition information reports that the device was implanted due to bilateral lower extremity deep venous thrombosis and pulmonary embolism.The patient is reported to continue to experience anxiety.It was reported that a patient underwent placement of the a trapease vena cava filter.The information received indicated that the filter malfunctioned and tilted, migrated, perforated the inferior vena cava (ivc) and the patient experienced and pulmonary embolism (pe).The patient is also reported to experience anxiety related to the device.The patient became aware of the migration and perforation approximately eleven and half years after implant, how the issues were identified and the mechanism of communicating this information to the patient has not been provided.The indication for the device implant was bilateral lower extremity deep vein thrombosis (dvt) and pe.The device was implanted via the left common femoral vein and deployed at the l2 position.There were no reported complications, venogram indicated that the ivc was clot free and of normal caliber.The patient¿s medical history has not been provided and there is currently no additional information available.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.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 complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion cannot be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.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.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt, migration and perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.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, clotting, pe and ivc occlusion do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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

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

Manufacturer Narrative

According to the information received in the patient profile from (ppf), filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc.The patient also reports deep vein thrombosis.

Manufacturer Narrative

As reported, the patient underwent placement of the a trapease inferior vena cava (ivc) filter.The indication for filter placement was bilateral leg deep vein thrombosis (dvt) and pulmonary embolism.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, perforation of the inferior vena cava (ivc), migration, and subsequent pulmonary embolism (pe).Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, dvt and anxiety related to the device.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 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.It was reported that there was perforation of the ivc; 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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• MDR Report Key: 6662958
• MDR Text Key: 78249666
• Report Number: 1016427-2017-00388
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0805609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN J-WIRE; UNKNOWN NEEDLE; UNKNOWN SHEATHS
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 48 YR