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

Model Number 466P306X

Device Problems Fracture (1260); Therapy Delivered to Incorrect Body Area (1508); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Perforation (2001)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for treatment of deep vein thrombosis (dvt).The device was implanted into the patient¿s l2 level.The device in the patient was positively identified by medical records.On or about five years and two months later, the patient experienced a pulmonary embolism and had a malposition of the trapease filter.This required the patient to have an additional non-cordis filter installed.Approximately nine years and two months after implantation, the patient received an exam of the abdomen which showed that the inferior vena cava filter (ivc) filter was malpositioned.On or about a month after that scan, the patient received another scan of the abdomen that noted her trapease filter was tilted and the non-cordis filter was present as well.Then in seven days, another scan was done on the patient that confirmed the previous diagnosis but also noted that the struts of the trapease filter extended beyond the lumen of the ivc and the filter has fractured.Five months later, the patient was diagnosed with a chronic left iliac vein occlusion.Both ivc filters were noted in this checkup and her trapease filter was seen in the lower right renal vein while the non-cordis filter was still in good position.The patient was advised that she needed to be anticoagulated for life.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.The product was not returned for analysis.Additionally, as the sterile lot number was not available, the device history record (dhr) 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.Venous occlusion or a pulmonary embolism do not represent a malfunction of the device.Without procedural films for review, the reported filter tilt, migration and fractures could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.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 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 reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the migration or reported strut fracture 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.However, 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 manufacturing process of the device; therefore no corrective action will be taken.

Event Description

As reported, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for treatment of deep vein thrombosis (dvt).The device was implanted into the patient¿s l2 level.The device in the patient was positively identified by medical records.On or about five years and one months later, the patient experienced a pulmonary embolism and had a malposition of the trapease filter.This required the patient to have an additional non-cordis filter installed.Approximately nine years and two months after implantation, the patient received an exam of the abdomen which showed that the inferior vena cava filter (ivc) filter was malpositioned.On or about a month after that scan, the patient received another scan of the abdomen that noted her trapease filter was tilted and the non-cordis filter was present as well.Then in seven days, another scan was done on the patient that confirmed the previous diagnosis but also noted that the struts of the trapease filter extended beyond the lumen of the ivc and the filter has fractured.Five months later, the patient was diagnosed with a chronic left iliac vein occlusion.Both ivc filters were noted in this checkup and her trapease filter was seen in the lower right renal vein while the non-cordis filter was still in good position.The patient was advised that she needed to be anticoagulated for life.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for treatment of deep vein thrombosis (dvt) unresponsive to anticoagulant therapy.The device was implanted at the patient¿s l2 level; however, a transverse placement was noted at the time of implant.Approximately five years later, the patient experienced a pulmonary embolism and had a malposition of the trapease filter.This required the patient to have an additional non-cordis filter installed.Approximately nine years and two months after implantation, the patient received an exam of the abdomen which showed that the inferior vena cava filter (ivc) filter was malpositioned.On or about a month after that scan, the patient received another scan of the abdomen that noted her trapease filter was tilted and the non-cordis filter was present as well.Then in seven days, another scan was done on the patient that confirmed the previous diagnosis but also noted that the struts of the trapease filter extended beyond the lumen of the ivc and the filter has fractured.Five months later, the patient was diagnosed with a chronic left iliac vein occlusion; although, there was no noted acute dvt.Also noted was chronic phlebotic changes to the left external iliac and femoral veins.Both ivc filters were noted in this checkup and her trapease filter was seen in the lower right renal vein while the non-cordis filter was still in good position.The patient was advised that she needed to be anticoagulated for life because of her history of multiple pulmonary emboli.Per the patient profile form (ppf), the filter has fractured and perforated the ivc, and there are blood clots, clotting and/or occlusion of the ivc.There have been no removal attempts.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.The dhr could not be completed.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.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 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.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots, pulmonary embolism 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.

Manufacturer Narrative

Please note weight is unknown.Please note expiration date and manufacturing date are unknown.Please note: : product - trapease pvcf fem/jug 55cm csi.Lot number: r0604881.Catalog number: 466p306au~tpmecc.According to the patient profile form (ppf).The device was positively identified by medical records.On or about five years and one months later, the patient experienced a pulmonary embolism and had a malposition of the trapease filter.This required the patient to have an additional non-cordis filter installed.Approximately nine years and two months after implantation, the patient received an exam of the abdomen which showed that the inferior vena cava filter (ivc) filter was malpositioned.On or about a month after that scan, the patient received another scan of the abdomen that noted her trapease filter was tilted and the non-cordis filter was present as well.Then in seven days, another scan was done on the patient that confirmed the previous diagnosis but also noted that the struts of the trapease filter extended beyond the lumen of the ivc and the filter has fractured.Five months later, the patient was diagnosed with a chronic left iliac vein occlusion; although, there was no noted acute dvt.Also noted was chronic phlebitic changes to the left external iliac and femoral veins.Both ivc filters were noted in this checkup and her trapease filter was seen in the lower right renal vein while the non-cordis filter was still in good position.The patient was advised that she needed to be anticoagulated for life because of her history of multiple pulmonary emboli.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.Per the patient profile form (ppf), the filter has fractured and perforated the ivc, and there are blood clots, clotting and/or occlusion of the ivc.There have been no removal attempts.The filter remains implanted; thus, unavailable for analysis.

Manufacturer Narrative

Complaint conclusion: as reported by the legal brief, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for treatment of deep vein thrombosis (dvt), unresponsive to anticoagulant therapy.The device was implanted at the patient¿s l2 level; however, a transverse placement was noted.The device was positively identified by medical records.On or about five years and one months later, the patient experienced a pulmonary embolism and had a malposition of the trapease filter.This required the patient to have an additional non-cordis filter installed.Approximately nine years and two months after implantation, the patient received an exam of the abdomen which showed that the inferior vena cava filter (ivc) filter was malpositioned.On or about a month after that scan, the patient received another scan of the abdomen that noted her trapease filter was tilted and the non-cordis filter was present as well.Then in seven days, another scan was done on the patient that confirmed the previous diagnosis but also noted that the struts of the trapease filter extended beyond the lumen of the ivc and the filter has fractured.Five months later, the patient was diagnosed with a chronic left iliac vein occlusion; although, there was no noted acute dvt.Also noted was chronic phlebotic changes to the left external iliac and femoral veins.Both ivc filters were noted in this checkup and her trapease filter was seen in the lower right renal vein while the non-cordis filter was still in good position.The patient was advised that she needed to be anticoagulated for life because of her history of multiple pulmonary emboli (pe).Per the patient profile form (ppf), the filter has fractured and perforated the ivc, and there are blood clots, clotting and/or occlusion of the ivc.There have been no removal attempts.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.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 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.It was also reported that there was perforation of the ivc; 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 it ivc filters.Blood clots, pe 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: 6896498
• MDR Text Key: 87455073
• Report Number: 1016427-2017-00618
• 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,Followup
• Report Date: 07/11/2018

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: 466P306AU
• Device Lot Number: R0604481
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 02/06/2018; 02/06/2018; 02/06/2018; 07/06/2018
• Supplement Dates FDA Received: 03/30/2018; 03/30/2018; 04/16/2018; 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE UNKNOWN DILATOR UNKNOWN INTRODU
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR