MAUDE Adverse Event Report: CORDIS CASHEL 466F220A; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

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

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Thrombosis (2100)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

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 optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, recurrent deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient suffered life-threatening injuries and damages, requiring extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

The implant date was confirmed to be accurate.The exact date of event is unknown.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 optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, recurrent deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient suffered life-threatening injuries and damages, requiring extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 3 years 2 months post implantation.The patient reports device unable to be retrieved, but no removal attempt has been made.The patient also reports suffering from, arrhythmia, and anxiety.

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, recurrent deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient suffered life-threatening injuries and damages, requiring extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior 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).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.The presence of these clots does not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter.Per the patient¿s medical records, the filter was implanted due to deep vein thrombosis, the filter was placed over the l2-l3 vertebral body.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, recurrent deep vein thrombosis (dvt) and pulmonary embolism (pe).Per the patient profile form (ppf), the patient reports device unable to be retrieved, but no removal attempt has been made.The patient also reports suffering from, arrhythmia, and anxiety.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 optease 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.Post procedure pulmonary embolism is a known potential adverse event associated with the use of the ivc filters.These events may be related to excessive clot burden from underlying patient specific factors.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.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

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 optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, recurrent deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient suffered life-threatening injuries and damages, requiring extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information was received per the patient¿s medical records: the filter was implanted due to left common femoral vein deep venous thrombosis, pulmonary emboli.The filter was placed over the l2-l3 vertebral body.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 3 years 2 months post implantation.The patient reports device unable to be retrieved, but no removal attempt has been made.The patient also reports suffering from, arrhythmia, and anxiety.

• Brand Name: 466F220A
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7637837
• MDR Text Key: 112322856
• Report Number: 1016427-2018-01581
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15777997
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR