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

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Death (1802); Occlusion (1984); Respiratory Failure (2484)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The exact date of death is unknown.The catalog number is unknown, if received it, will be provided.Complaint conclusion: it was reported that a patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused great bodily harm to the patient including, but not limited to, a pulmonary embolism, directly and proximately causing respiratory failure and death approximately one month after the filter had been implanted.As a direct and proximate result of these malfunctions, the patient suffered fatal injuries, damages, and untimely death.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed as such in the instructions for use (ifu).There are possible patient and pharmacological factors that may have contributed to the reported event.The reported pulmonary embolism could not be confirmed without films for review.Factors that may have influenced the event include patient and pharmacological.The brief reported death: however, a clinical conclusion relating to the function of the ivc filter could not be determined as to the cause of the event.With the limited information available, it is not possible to draw a conclusion between the reported events and the device, there is nothing to suggest that there is a design or manufacturing related issue; 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 great bodily harm to the patient including, but not limited to, a pulmonary embolism, directly and proximately causing respiratory failure and death approximately one month after the filter had been implanted.As a direct and proximate result of these malfunctions, the patient suffered fatal injuries, damages, and untimely death.

Manufacturer Narrative

Additional information was provided and is available in: (age at the time of event, date of birth), (event date), (event description), (relevant history race and medical history), (concomitant medical products and therapy dates), (date received by the manufacturer and pma/510(k) number), (evaluation codes), the implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused great bodily harm to the patient including, but not limited to, a pulmonary embolism, directly and proximately causing respiratory failure and death approximately six weeks after the filter had been implanted.As a direct and proximate result of these malfunctions, the patient suffered fatal injuries, damages, and untimely death.The following additional information received per the medical records indicate that patient had a history of acute deep vein thrombosis (dvt).Additionally, medical records indicate ivc filter was placed below he renal veins and above the bifurcation of the iliac veins.Excellent apposition was noted.According to the information received in the patient profile from (ppf), patient reported blood clots, clotting, and/or occlusion of the ivc.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of the trapease inferior vena cava (ivc).Filter.Per the medical records, the patient had a history of acute deep vein thrombosis (dvt).The ivc filter was placed below the renal veins and above the bifurcation of the iliac veins.Excellent apposition was noted.The filter subsequently malfunctioned and caused great bodily harm to the patient including, but not limited to, a pulmonary embolism, directly and proximately causing respiratory failure and death approximately six weeks after the filter had been implanted.According to the information received in the patient profile from (ppf), patient reported blood clots, clotting, and/or occlusion of the ivc.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.Blood clots, pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Pulmonary embolism associated respiratory failure is a known potential adverse vent associated to the use of the trapease device.Death is a known potential complication associated with the use of the ivc filter devices and is listed in the ifu as such; in this case, the death was related to respiratory failure secondary to pulmonary emboli.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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7040801
• MDR Text Key: 92314928
• Report Number: 1016427-2017-00750
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 07/23/2018; 08/31/2018
• Supplement Dates FDA Received: 08/22/2018; 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIX (6) FRENCH LEFT FEMORAL SHEATH PIGTAIL CATHETER
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 76 YR