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

Catalog Number 466P306AU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Calcium Deposits/Calcification (1758)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter.The device in the patient was positively identified by medical records.On or about four years and five months after, the patient received a scan on the abdominal region after complaints of abdominal pain.The scan revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac showed increased amount of calcification, much greater than the expected for the patient¿s age.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s malfunction, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring 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, not limited to the apprehension and risk associated with retaining a defective device inside her body.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 event.The trapease inferior 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.Abdominal pain also does not represent a malfunction of the device.The brief also mentioned the formation of calcification.Calcification is the accumulation of calcium salts in a body tissue.It is transported through the blood stream.Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden.Calcification within a patient does not represent a device malfunction.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, and the device history record (dhr) results, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation of the device; therefore no corrective action will be taken.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter.The device in the patient was positively identified by medical records.On or about four years and five months after, the patient received a scan on the abdominal region after complaints of abdominal pain.The scan revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac showed increased amount of calcification, much greater than the expected for the patient¿s age.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s malfunction, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring 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, not limited to the apprehension and risk associated with retaining a defective device inside her body.

Manufacturer Narrative

Additional information was received from the patient profile form (ppf) that the patient states she has pain, suffering, and has fears of future additional injuries that the implant has moved or will move and cause injury or death.The patient states she had a stroke after the filter was implanted.Medical records received indicate that the patient had acute appendicitis approximately 4 ½ years after the filter was placed.The patient¿s appendix were removed and there were no procedural complications.The record also states peritoneoscopy reveals some ahesions to the anterior abdominal wall in the lower abdomen from previous surgeries.Additional medical records received indicated the patient presented to the hospital with some atypical symptoms that were tia-like with left-sided numbness approximately two months later; however, during her workup, she had a borderline abnormal ekg with some t-wave abnormality noted in inferior leads, as well as serial cardiac enzymes, all of which showed elevated troponin in the range of 0.4-0.5.The patient had episodes of chest pain regularly.Left heart catheterization with selective coronary angiography and left ventriculography revealed very minimal coronary artery disease and normal left ventricular function.The patient was discharged without any treatment.The patient also had a ct of the head which showed no ct evidence of an acute infarct or intracranial hemorrhage.An mri also showed no evidence of a cerebrovascular accident (cva).A venous doppler showed no evidence of bilateral lower extremity deep venous thrombosis.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was received from a new legal filing with the patient reporting migration of the filter to the abdomen.The product remains implanted and is thus not available for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter.The indication for filter placement is not available.The device in the patient was positively identified by medical records.Approximately four years and five months after, the patient received a scan on the abdominal region after complaints of abdominal pain.The scan revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac veins showed increased amount of calcification, much greater than the expected for the patient¿s age.Per the patient profile form (ppf), the patient states she has pain, suffering, and fear and had a stroke post filter implantation.Additional medical records received indicated the patient presented to the hospital with some atypical symptoms that were tia-like with left-sided numbness; however, during her workup, she had a borderline abnormal ekg with some t-wave abnormality noted in inferior leads, as well as serial cardiac enzymes, all of which showed elevated troponin in the range of 0.4-0.5.The patient had episodes of chest pain regularly.Left heart catheterization revealed very minimal coronary artery disease and normal left ventricular function.The patient was discharged without any treatment.The patient also had a ct of the head which showed no ct evidence of an acute infarct or intracranial hemorrhage.An mri also showed no evidence of a cerebrovascular accident (cva).A venous doppler showed no evidence of bilateral lower extremity deep venous thrombosis.Additional information was received where the patient reported migration of the filter to the abdomen.The filter remains implanted; thus, unavailable for analysis.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.Vascular calcification does not represent a device malfunction and may be related to underlying patient related issues.Stroke is a known potential adverse event associated with the use of the trapease device.Anxiety 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.

Manufacturer Narrative

Additional information was received from an updated patient profile firm.Per the patient profile form (ppf), the patient reports a stroke after filter implant.Per the medical records, the patient had acute appendicitis, and had a laparoscopic appendectomy.A ct of the abdomen at that time noted the ivc filter in place.Medical history includes smoking and aortic insufficiency.2 months later, the patient had a left heart catheterization for atypical symptoms, tia-like with left sided numbness with an abnormal ekg.The impression from the catheterization included very minimal coronary artery disease (nothing obstructive) and normal left ventricular function.A cta of the neck revealed mild narrowing of the proximal left common carotid artery with the remainder of the neck structures being unremarkable.A ct of the head at this time revealed no intraluminal filling defects or significant stenosis.An mri showed no evidence of a cva, no intracranial abnormality identified.As reported, the patient had implant of a trapease permanent inferior vena cava (ivc) filter.The patient reporting migration of the filter to the abdomen.A ct scan, four years and five months after implant, revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac showed increased amount of calcification.Per the patient profile form (ppf), the patient reports pain, suffering, and fear.Per the patient profile form (ppf), the patient reports a stroke after filter implant.Per the medical records, the patient had acute appendicitis, and had a laparoscopic appendectomy.A ct of the abdomen at that time noted the ivc filter in place.Medical history includes smoking and aortic insufficiency.2 months later, the patient had a left heart catheterization for atypical symptoms, tia-like with left sided numbness with an abnormal ekg.The impression from the catheterization included very minimal coronary artery disease (nothing obstructive) and normal left ventricular function.A cta of the neck revealed mild narrowing of the proximal left common carotid artery with the remainder of the neck structures being unremarkable.A ct of the head at this time revealed no intraluminal filling defects or significant stenosis.An mri showed no evidence of a cva, no intracranial abnormality identified.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.Vascular calcification does not represent a device malfunction and may be related to underlying patient related issues.Anxiety 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.

Manufacturer Narrative

As reported, the underwent placement of a trapease vena cava filter.The patient is reported to have had a history of smoking and aortic insufficiency.The indication for the filter placement was reported to be for the prevention of pulmonary embolism (pe) and deep vein thrombosis (dvt).Approximately four years and five months after the implantation, the patient underwent a computerized tomography (ct) scan that revealed that the filter was in the region of the abdominal aorta and that the iliac vein showed increased amounts of calcification.The patient further reported having experienced abdominal pain, suffering, emotional distress and fear associated with the filter.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 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 migration could not be confirmed and the exact cause could not be determined.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 ivc 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.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.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 brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter.The device in the patient was positively identified by medical records.On or about four years and five months after, the patient received a scan on the abdominal region after complaints of abdominal pain.The scan revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac showed increased amount of calcification, much greater than the expected for the patient¿s age.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s malfunction, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring 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, not limited to the apprehension and risk associated with retaining a defective device inside her body.Additional information was received from the patient profile form (ppf) that the patient states she has pain, suffering, and has fears of future additional injuries that the implant has moved or will move and cause injury or death.The patient states she had a stroke after the filter was implanted.Medical records received indicate that the patient had acute appendicitis approximately 4 ½ years after the filter was placed.The patient¿s appendix were removed and there were no procedural complications.The record also states peritoneoscopy reveals some ahesions to the anterior abdominal wall in the lower abdomen from previous surgeries.Additional medical records received indicated the patient presented to the hospital with some atypical symptoms that were tia-like with left-sided numbness approximately two months later; however, during her workup, she had a borderline abnormal ekg with some t-wave abnormality noted in inferior leads, as well as serial cardiac enzymes, all of which showed elevated troponin in the range of 0.4-0.5.The patient had episodes of chest pain regularly.Left heart catheterization with selective coronary angiography and left ventriculography revealed very minimal coronary artery disease and normal left ventricular function.The patient was discharged without any treatment.The patient also had a ct of the head which showed no ct evidence of an acute infarct or intracranial hemorrhage.An mri also showed no evidence of a cerebrovascular accident (cva).A venous doppler showed no evidence of bilateral lower extremity deep venous thrombosis.Additional information was received from a new legal filing with the patient reporting migration of the filter to the abdomen.Additional information was received from an updated patient profile firm.Per the patient profile form (ppf), the patient reports a stroke after filter implant.Per the medical records, the patient had acute appendicitis, and had a laparoscopic appendectomy.A ct of the abdomen at that time noted the ivc filter in place.Medical history includes smoking and aortic insufficiency.2 months later, the patient had a left heart catheterization for atypical symptoms, tia-like with left sided numbness with an abnormal ekg.The impression from the catheterization included very minimal coronary artery disease (nothing obstructive) and normal left ventricular function.A cta of the neck revealed mild narrowing of the proximal left common carotid artery with the remainder of the neck structures being unremarkable.A ct of the head at this time revealed no intraluminal filling defects or significant stenosis.An mri showed no evidence of a cva, no intracranial abnormality identified.According to the discovery form, the patient received the ivc filter for prevention of pulmonary embolism (pe) and deep vein thrombosis (dvt).Medical conditions and treatments alleged to be attributable to the implanted ivc filter include pain.As a result of the device defect, the patient reports the need for additional follow up care, medical monitoring and more treatments than usual, which caused and continues to cause emotional distress.

• 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: 6898341
• MDR Text Key: 87594994
• Report Number: 9616099-2017-01466
• 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: 07/11/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15167337
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 05/08/2018; 06/14/2018; 06/25/2018; 05/08/2019; 06/24/2019
• Supplement Dates FDA Received: 06/06/2018; 06/21/2018; 07/06/2018; 05/16/2019; 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening