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

Model Number 466P306X

Device Problems Fracture (1260); Migration (4003)

Patient Problems Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of the trapease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter fracture.As a direct and proximate result, 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, pain and suffering, and other damages.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 inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 reported filter fracture could not be confirmed and the exact cause could not be determined.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter fracture.As a direct and proximate result, 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, pain and suffering, and other damages.

Manufacturer Narrative

Addendum for additional information received:the following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events approximately 155 months post implantation.The ppf states that the filter struts perforated outside of the inferior vena cava (ivc).The entire filter migrated other than to the heart.It was also reported that the device was unable to be retrieved, however, there have been no known attempts to remove the device.The fractured filter struts remained in the body adjacent to the lumbar spine.The patient also reports to be suffering from mental anguish, fear, anxiety, panic attacks, depression, post-traumatic stress disorder (ptsd), being unable to go to sleep and eat.According to the information received in the medical records, the patient¿s pre-operative diagnosis was right deep venous thrombosis (dvt), disseminated intravascular coagulation and inability to properly anticoagulate.The patient is noted to be an intravenous heroin abuser and was initially admitted for sepsis.The patient was found to have deep vein thrombosis of the right thigh and disseminated intravascular coagulation with a large abscess on the right thigh which required to have the disseminated intravascular coagulation corrected.The filter was implanted as the patient was high risk to have a pulmonary embolism (pe) from a right thigh common femoral deep venous thrombosis.The trapease using the -arm was placed exactly at the l2-l3 interface after assessing guidance from the right common femoral vein.The abscess cavity with a penrose drain had residual clot which was then irrigated out.There was a small amount of purulent material in there, and it was packed.The patient tolerated the procedure well.The patient was transferred to recovery in stable condition.As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter fracture.Per the patient profile form (ppf), the patient reports filter struts perforated outside of the inferior vena cava (ivc).The entire filter migrated other than to the heart.It was also reported that the device was unable to be retrieved, however, there have been no known attempts to remove the device.The fractured filter struts remained in the body adjacent to the lumbar spine.The patient also reports post-traumatic stress disorder (ptsd).Per the medical records, the pre-operative diagnosis was right deep venous thrombosis (dvt), disseminated intravascular coagulation and inability to properly anticoagulate.The patient is an intravenous heroin abuser and was initially admitted for sepsis.The patient had deep vein thrombosis of the right thigh and disseminated intravascular coagulation with a large abscess on the right thigh which required to have the disseminated intravascular coagulation corrected.The trapease was placed exactly at the l2-l3 interface.The patient tolerated the procedure well.The patient was transferred to recovery in stable condition.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.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.The instructions for use (ifu) states filter fracture with perforation 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.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.Post traumatic stress disorder 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: 8346383
• MDR Text Key: 136495066
• Report Number: 1016427-2019-02518
• 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
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2008
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0605639
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR