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

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Coagulation Disorder (1779); Perforation (2001); Anxiety (2328)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.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.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, after an unspecified time after the patient underwent placement of an optease vena cava filter, the filter subsequently malfunctioned and caused injury and damages to including, but not limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the patient suffered serious injuries and damages, and will require extensive medical care and treatment.The following additional information received per the medical records indicates, that the patient has compromised respiratory system and severe constant chest pain on or about two years and two months post implantation.Additional information as reported by a legal short form states that the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting and perforation of the inferior vena cava filter.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required 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

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages including, but not limited to, severe and constant chest pains and compromised respiratory system.Per the medical records, the patient has compromised respiratory system and severe constant chest pain on or about two years and two months post implantation.Per additional information received, the patient also underwent placement of a trapease vena cava filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting and perforation of the inferior vena cava filter.The filter remains implanted; thus, 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 optease and trapease vena cava filters are 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.It was 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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Chest pain and respiratory abnormality do not represent a device malfunctions and may be related to underlying patient related issues.With the limited information available it is not possible to adequately assess the contributing factors to these events.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

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.A device history record (dhr) review could not be performed as a lot number was not provided.

Event Description

According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 4 years and 10 months post implantation.The patient reports anxiety.

Manufacturer Narrative

After further review of additional information received the following sections b5, g4, g7, h2, and h6 have been updated accordingly.Additional information is pending and will be submitted within 30 days upon receipt.This report is related to (b)(4).

Event Description

According to the information received in the discovery form, patient became aware of the reported events approximately 4 years and 11 months post implantation.The patient reports clotting.The patient also received blood transfusion for the blood clots and partial removal of fibroids.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, and h6 have been updated accordingly.Section d6 correction: patient code 'coagulopathy' no longer a reportable code per additional information received.This report is related to (b)(4).As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of hypertension.The indication for the filter placement was reported to be a right femoral deep vein thrombosis (dvt) with embolization.Approximately two years and two months after the implant of the optease retrievable vena cava filter, the patient experienced compromised respiratory system and severe constant chest pain.At some point, the patient is reported to have undergone placement of a trapease vena cava filter.From the report, it is unclear when this filter was implanted or why.Approximately four years and ten months after the initial filter placement, the patient became aware that the trapease filter was associated with filter tilt, and with perforation of the inferior vena cava (ivc).The patient further reported having experienced mental anguish, anxiety and fear associated with the filter.The patient has additionally reported clotting, unspecified.The patient also received blood transfusion for the blood clots and partial removal of fibroids.There is currently no additional information available for review.The optease retrievable vena cava filter 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 trapease vena cava filter 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.Cordis vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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, clotting, and device occlusion related to clotting do not indicate a device malfunction, furthermore it is unclear if the blood clotting is related to fibroids or the filter.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without images or procedural films for review, the reported filter tilt and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Additionally, the timing and mechanism of the filter tilt is unknown.The reported ivc perforation could not be confirmed without procedural films for review.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Due to the nature of the complaint, the reported chest pain and respiratory compromise experienced by the patient could not be confirmed and the exact cause could not be determined.Anxiety does not represent a device malfunction and may be related to underling patient specific issues.Given the limited information available for review, there is nothing to suggest that a malfunction in 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
• MDR Report Key: 8262397
• MDR Text Key: 133706995
• Report Number: 1016427-2019-02435
• 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,Followup,Followup
• Report Date: 09/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• 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: 08/16/2019
• Patient Sequence Number: 1
• Patient Age: 53 YR