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

Catalog Number 466P306AU

Device Problems Bent (1059); Kinked (1339); Retraction Problem (1536); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.Approximately seven months post placement, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, significant migration and the filter was significantly tilted, buckled and bent and approximately three struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, 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.Without procedural films or the referenced ct scan for review, the reported filter tilt, migration and ivc perforation could not be confirmed and the exact cause could not be determined.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 timing and mechanism of the filter tilt is unknown at this time.Filter tilt has been known to occur at the time of placement or retrieval of the filter.Additionally, specific physical and mechanical characteristics of each filter may be influenced in different ways by the specific clinical scenario, ivc anatomy and compliance, and the underlying hemodynamics to which the device is exposed.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, the patient underwent placement of defendants¿ trapease vena cava filter.  approximately seven months post placement, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, significant migration and the filter was significantly tilted, buckled and bent and approximately three struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient had a history of pulmonary embolism (pe), chronic renal failure and multiple orthopedic hardware from previous back operations.Due to the patient¿s renal failure, less contrast was used during the implantation procedure and a complete exam could not be performed however the vena cava is reported to have been the adequate size.The filter was deployed without complications and the patient was taken to recovery in good condition.According to the information received in the patient profile form (ppf), the patient became aware of the reported events eight years and thirty days post implantation.The filter is reported to be embedded in the ivc and the patient reports to be suffering from anxiety.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient had a history of pulmonary embolism (pe), chronic renal failure and multiple orthopedic hardware from previous back operations.Due to the patient¿s renal failure, less contrast was used during the implantation procedure and a complete exam could not be performed however the vena cava is reported to have been the adequate size.The filter was deployed without complications and the patient was taken to recovery in good condition.Approximately seven months post placement the patient underwent an updated computerized tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to significant migration and the filter being tilted, buckled and bent and approximately three struts significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.According to the information received in the patient profile form (ppf), the patient became aware of the reported events eight years and thirty days post implantation.The filter is reported to be embedded in the ivc and the patient reports to be suffering from anxiety.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot r1008322 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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 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.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.Kink/bent damages to the filter and struts are known potential product malfunctions associated with the use of the filter device.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 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.

• 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: 6787830
• MDR Text Key: 82485345
• Report Number: 1016427-2017-00522
• 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
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1008322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR