MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Embolus (1830); Occlusion (1984)

Event Date 04/06/2006

Event Type  Death  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to migration of the inferior vena cava (ivc) filter, resulting in the death of the patient.As a direct and proximate result of these malfunctions.The patient suffered fatal injuries, damages and untimely death.As a further proximate result, the patient¿s family member has suffered and will continue to suffer from the wrongful and premature death of the patient.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.An inferior vena cava (ivc) 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 medical records/autopsy report available for review, the reported migration of the ivc filter is unable to be confirmed.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 events reported that the patient experienced may be cardiac related and without medical records available the clinical cause is unable to be conclusively determined.The untimely expiration of the patient is unfortunate, however, 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 trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to migration of the inferior vena cava (ivc) filter, resulting in the death of the patient.As a direct and proximate result of these malfunctions.The patient suffered fatal injuries, damages and untimely death.As a further proximate result.The patient¿s sister has suffered and will continue to suffer from the wrongful and premature death of her sister.

Manufacturer Narrative

Additional information received per the patient profile form (ppf) states that the patient experienced migration of the filter to the heart, blood clots, clotting and occlusion of the inferior vena cava.Fracture is indicated on the form; however, the form also states that there is no claim that the filter was fractured.Additional information received per the medical records indicate that the patient had a history of saddle pulmonary embolus, shortness of breath, right ventricular (rv) dysfunction, morbid obesity, hypertension, hematuria, palpitations, chest pain and diabetes.  the filter was deployed via the right femoral vein.There were no significant complications. four days after the index procedure, the patient was found to be in ventricular fibrillation.She coded and was pronounced dead.  the autopsy report states the inferior vena cava filter was found within the right atrium.A portion of the filter was caught within the tricuspid valve.The certificate of death states that the cause of death was cardiopulmonary arrest, recurrent pulmonary emboli and migration of inferior vena cava filter.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per the medical records, the patient had a history of saddle pulmonary embolus, shortness of breath, right ventricular (rv) dysfunction, morbid obesity, hypertension, hematuria, palpitations, chest pain and diabetes.The filter was deployed via the right femoral vein.There were no significant complications.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to migration of the inferior vena cava (ivc) filter, resulting in the death of the patient.Per the patient profile form (ppf), the patient experienced migration of the filter to the heart, blood clots, clotting and occlusion of the inferior vena cava.Fracture is indicated on the form; however, the form also states that there is no claim that the filter was fractured.Four days after the index procedure, the patient was found in ventricular fibrillation.Resuscitation was attempted; however, was unsuccessful and the patient was pronounced dead.The autopsy report states the inferior vena cava filter was found within the right atrium.A portion of the filter was caught within the tricuspid valve.The certificate of death states that the cause of death was cardiopulmonary arrest, recurrent pulmonary emboli and migration of inferior vena cava filter.The filter is 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.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.Blood clots, pulmonary emboli and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 7729218
• MDR Text Key: 115339414
• Report Number: 1016427-2018-01697
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2019
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 11/01/2018; 01/03/2019
• Supplement Dates FDA Received: 12/27/2018; 02/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 43 YR
• Patient Weight: 159