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

Catalog Number 466P306X

Device Problems Fracture (1260); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Occlusion (1984); Internal Organ Perforation (1987); Perforation of Vessels (2135); Pseudoaneurysm (2605); No Code Available (3191)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an trapease vena cava filter and for which the catalog and lot number is not currently available.Additional information is pending and will be submitted within 30 days upon receipt.This report is a follow up report to mfr number 9616099-2016-00268 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.

Event Description

As reported by the legal brief, the patient had a trapease vena cava filter implanted.The filter subsequently malfunctioned and caused injury to the patient, including fracture, tilt, migration and perforation.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, and required extensive medical care and treatment.The following additional information received per the patient profile from (ppf) indicates that the filter perforated the inferior vena cava (ivc) and into organs, stenosis of the ivc and pseudo aneurysm of the ivc.The patient had the filter removed fourteen years and five months post implantation.Some fractured struts remain deeply embedded in the ivc wall and one is embedded within the right ventricular side of the heart.The patient also reports to be suffering from pain and anxiety.According to the medical records, the patient had a history of chronic lower extremity deep vein thrombosis (dvt) and chronic occlusion of the left iliac veins.The patient tolerated the index procedure well and the filter was successfully deployed.

Manufacturer Narrative

As reported, the patient had a trapease inferior vena cava (ivc) filter implanted.Per the medical records, the patient had a history of chronic lower extremity deep vein thrombosis (dvt) and chronic occlusion of the left iliac veins.The patient tolerated the index procedure well and the filter was successfully deployed.The filter subsequently malfunctioned and caused injury to the patient, including fracture, tilt, migration and perforation.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, and required extensive medical care and treatment.The following additional information received per the patient profile from (ppf) indicates that the filter perforated the inferior vena cava (ivc) and into organs, stenosis of the ivc and pseudo aneurysm of the ivc.The patient had the filter removed fourteen years and five months post implantation.Some fractured struts remain deeply embedded in the ivc wall and one is embedded within the right ventricular side of the heart.The patient also reports to be suffering from pain and anxiety.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.Without procedural films for review, the reported filter tilt, migration, fracture-separation and perforation could not be confirmed.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 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.The brief also reported 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.Occlusive thrombosis/occlusion within ivc does not represent a device malfunction.Anxiety and pain do not represent device malfunctions and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient comorbidities, 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.(b)(4).

Manufacturer Narrative

Section h6: patient code '3191' was used as there are no codes available for 'post thrombotic syndrome', and "collateral circulation".It was reported that a patient had a trapease vena cava filter implanted.The information provided indicated that the filter subsequently fractured, perforated, tilted and migrated.According to information provided by the patient, the filter perforated the inferior vena cava (ivc) and into organs, there was stenosis of the ivc and pseudo aneurysm of the ivc.The patient had the filter removed fourteen years and five months post implant.Approximately one month later a computed tomography (ct) venogram was performed for follow up evaluation of the ivc and the retained filter fragments.The evaluation revealed a new fractured ivc tine embedded within the right ventricular side of the interventricular septum of the patient¿s heart.Approximately 2 months later a ct angiogram of the chest showed part of the fragment intraluminal in the right ventricle.The patient also reports to be suffering from pain and anxiety.According to the medical records, the patient had a history of chronic lower extremity deep vein thrombosis (dvt) and chronic occlusion of the left iliac veins.The patient tolerated the index procedure well and the filter was successfully deployed.Additional information provided by the patient indicated that the patient had s protein deficiency and was taken off anticoagulation postpartum.The patient reports multiple fractures of the filter, with one fractured component having migrated along the left anterior caval wall and is superior to the filter apex.The patient also reports chronic thrombotic occlusion of the left common iliac vein requiring recanalization and stenting, enlarged pelvic venous collaterals, chronic non-occlusive dvt of the left external iliac vein, iliac pta, and residual ivc pseudoaneurysm.The patient is experiencing lower extremity pain, post thrombotic syndrome symptoms, numbness, and stenosis at level of the prior filter.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 reported filter tilt, migration, fracture-separation and perforation could not be confirmed.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 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 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.The brief also reported 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.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).Collateral circulation develops as a result of inherent circulation patterns being impeded.Occlusive thrombosis/occlusion within ivc does not represent a device malfunction.Anxiety, numbness and pain do not represent device malfunctions and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient comorbidities, 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7088061
• MDR Text Key: 93889181
• Report Number: 1016427-2017-00864
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 19 YR