MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problems Fracture (1260); Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)

Event Date 09/18/2013

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.The exact filter implantation date is unknown.Complaint conclusion: as reported, the patient underwent placement of a trapease inferior vena cava filter.The filter subsequently malfunctioned and caused injuries and damages to the patient, including but not limited to extensive deep vein thrombosis (dvt) of the lower extremities, occlusion of the ivc (inferior vena cava) below and including the ivc filter.As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain, 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.The trapease retrievable 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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Blood clots and thrombus within the device do not represent a device malfunction.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 event is related to the design and/or 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 plaintiff underwent placement of one of a trapease filters.The filter subsequently malfunctioned and caused injuries and damages to the patient, including but not limited to extensive deep vein thrombosis (dvt) of the lower extremities, occlusion of the ivc below and including the ivc filter.As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.

Manufacturer Narrative

Describe event or problem: the following additional information received per the patient profile from (ppf) indicates that the filter fractured, perforated the ivc, migrated and was embedded in the wall of the ivc and that the patient had blood clots, clotting and stenosis.The filter struts are reported to be retained in the common femoral vein and on the right and external iliac vein.The patient also reports to have mental anguish, trouble walking and pain.According to the medical records, the patient¿s pre-operative diagnosis was venous thrombosis with contraindication to anticoagulation.The filter was deployed below the level of the origin of the right renal vein without any reported complications.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient¿s pre-operative diagnosis was venous thrombosis with contraindication to anticoagulation.The filter was deployed below the level of the origin of the right renal vein without any reported complications.The filter subsequently malfunctioned and caused injuries and damages to the patient, including but not limited to extensive deep vein thrombosis (dvt) of the lower extremities, occlusion of the inferior vena cava (ivc) and the ivc filter.As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.Per the patient profile from (ppf), the filter fractured, perforated the ivc, migrated and was embedded in the wall of the ivc and that the patient had blood clots, clotting and stenosis.The filter struts are reported to be retained in the common femoral vein and on the right and external iliac vein.The patient also reports to have mental anguish, trouble walking and pain.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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.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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it 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.Stenosis is a known potential adverse event associated with the use of an ivc filter and difficulty walking does not represent a device malfunction.Blood clots 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.Corrected data: (product code).

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• MDR Report Key: 6928205
• MDR Text Key: 89080773
• Report Number: 1016427-2017-00676
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• 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: 466P306X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/14/2017
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR