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

Model Number 466P306X

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Anxiety (2328)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment and prevention of deep venous thrombosis (dvt), cholecystitis and chotelithiasis.The device was implanted at the l3 level of the patient¿s right femoral vein region.The device in the patient was positively identified by medical records and product implant label.On or about four years and five months post implant, the patient had a scan done due to complaints of abdominal pain, which showed the inferior vena cava (ivc) filter that region.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 installation, 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.Additionally, as the sterile lot number was not available, the device history record (dhr) review could not 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.Abdominal pain also does not represent a malfunction of the device.Clinical factors that may have influenced the event include patient, pharmacological, or other comorbidities and are not necessarily related to the implantation of the filter.Without available films or medical records for review we are unable to confirm correlation of the related complaints with the device.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.

Event Description

As reported by the legal brief, the patient the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment and prevention of deep venous thrombosis (dvt), cholecystitis and chotelithiasis.The device was implanted at the l3 level of the patient¿s right femoral vein region.The device in the patient was positively identified by medical records and product implant label.On or about four years and five months post implant, the patient had a scan done due to complaints of abdominal pain, which showed the inferior vena cava (ivc) filter that region.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 installation, 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

After further review of additional information received the following sections have been updated accordingly.According to the information received in the short form, the patient reports migration of the ivc filter and abdominal pain.Product problem (e.G., defects/malfunctions).As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for the prevention of deep venous thrombosis (dvt).The indication for ivc filter placement was cholecystitis and cholelithiasis and morbid obesity prior to cholecystectomy.The device was implanted below the level of the renal veins and above the bifurcation.A venogram noted the ivc to be less than two centimeters in diameter.Approximately 4.5 years post implant, the patient had a ct done due to abdominal pain, which showed the inferior vena cava (ivc) filter in that region.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.Per the patient profile form (ppf), the patient reports suffering from anxiety.The filter is embedded and has tilted.There has been no attempt to retrieve the device.The filter remains implanted; thus, unavailable for analysis.According to the information received in the short form, the patient reports migration of the ivc filter and abdominal pain.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.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 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.Anxiety and abdominal 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.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

Complaint conclusion: as reported, the patient the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for the prevention of deep venous thrombosis (dvt).The indication for ivc filter placement was cholecystitis and cholelithiasis and morbid obesity prior to cholecystectomy.The device was implanted below the level of the renal veins and above the bifurcation.A venogram noted the ivc to be less than 2cm in diameter.The device in the patient was positively identified by medical records and product implant label.Approximately four years and five months post implant, the patient had a scan done due to complaints of abdominal pain, which showed the inferior vena cava (ivc) filter in that region.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.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.Per the patient profile form (ppf), the patient reports suffering from anxiety.The filter is embedded and has tilted.There has been no attempt to retrieve the device.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 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.Anxiety and abdominal 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 brief, as reported by the legal brief, the patient the patient underwent a surgical procedure to implant a trapease permanent inferior vena cava (ivc) filter for the prevention of deep venous thrombosis (dvt).The indication for ivc filter placement was cholecystitis and cholelithiasis and morbid obesity prior to cholecystectomy.The device was implanted below the level of the renal veins and above the bifurcation.A venogram noted the ivc to be less than 2cm in diameter.The device in the patient was positively identified by medical records and product implant label.On or about four years and five months post implant, the patient had a scan done due to complaints of abdominal pain, which showed the inferior vena cava (ivc) filter in that region.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 installation, 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.Per the patient profile form (ppf), the patient reports suffering from anxiety.The filter is embedded and has tilted.There has been no attempt to retrieve the device.The filter remains implanted; thus, unavailable for analysis.

Manufacturer Narrative

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

• 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: 6893160
• MDR Text Key: 87348928
• Report Number: 1016427-2017-00613
• 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
• Report Date: 06/26/2018

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 Expiration Date: 03/31/2015
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15602826
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 09/01/2017; 05/08/2018; 06/01/2018
• Supplement Dates FDA Received: 03/27/2018; 06/01/2018; 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR