MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306AU

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

Patient Problems Death (1802); Myocardial Infarction (1969); Perforation (2001); Perforation of Vessels (2135); Chronic Obstructive Pulmonary Disease (COPD) (2237); Anxiety (2328); Respiratory Failure (2484); No Code Available (3191)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.Approximately six (6) years post index procedure the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, the filter had significantly perforated the inferior vena cava (ivc).As a direct and proximate result of these malfunctioned.The patient suffered and will continue to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not 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.The legal briefing mentioned a perforation of the ivc wall.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Also, with the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or 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 defendants¿ trapease vena cava filter.Approximately 6 years post index procedure the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, the filter had significantly perforated the inferior vena cava (ivc).As a direct and proximate result of these malfunctioned.The patient suffered and will continue to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Concomitant medical products: unknown.018 nitinol guidewire, unknown j-tip guidewire, unknown 4 french micro kit introducer, unknown glow and tell tape, 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 brief, the patient underwent placement of defendants¿ trapease vena cava filter.Approximately 6 years post index procedure, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, the filter had significantly perforated the inferior vena cava (ivc).As a direct and proximate result of these malfunctioned.The patient suffered and will continue to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The following additional information was received per the patient¿s medical records: the filter was deployed into the infrarenal inferior vena cava.Approximately 6 years and 8 months post implantation, patient underwent a computerized topography scan.According to radiology report: superior extent of ivc filter is the at the l2-l3 disc space.Inferior extent l4 vertebral body.A total of five prongs have perforated the ivc, series 3 image 45.Maximum distance prong perforated is 2mm, series 3 image 45.No significant tilt was seen on coronal or sagittal images.Diameter of ivc directly above filter measures 21mmx25mm, series 3, image 35.According to certificate of death, patient passed away 6 years 10 months post implantation due to acute respiratory failure, influenza type a, and end stage chronic obstructive pulmonary disease with aortic aneurysm with repair, coronary artery disease, myocardial infarction as contributing conditions.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 6 years and 8 months post implantation.The patient reports perforation of filter strut(s) outside the ivc.The patient also reported suffering from anxiety.

Manufacturer Narrative

After further review of additional information received the following sections date received by mfr., type of reports, type of reportable event, if follow-up, what type, and evaluation codes have been updated accordingly.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter had perforated the perforated the inferior vena cava (ivc) and the patient expired.According to the information provided the patient became aware of the reported events approximately 6 years and 8 months post implant, the patient also reported experiencing anxiety.The indication for the filter implant was deep vein thrombosis.The filter was placed via the right internal jugular vein and deployed in the infrarenal location of the inferior vena cava.There were no reported complications.Approximately 6 years and 8 months post implantation patient underwent a computerized tomography scan which revealed a total of five prongs had perforated the ivc.With the medical records a death certificate was also provided showing that the patient expired approximately 6 years and ten months post implant.The immediate cause of death listed was acute respiratory failure, influenza type a and end stage chronic obstructive pulmonary disease.Other significant conditions listed were aortic aneurysm with repair, coronary artery disease and myocardial infarction.There is currently no additional information available for review.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 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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed or further clarified.The death certificate listed the cause of death as respiratory failure, influenza type a and end stage chronic obstructive pulmonary disease with secondary condition of aortic aneurysm repair, coronary artery disease and myocardial infarction, these events do not represent a device malfunction and may be related to underlying patient specific issues.Anxiety also does not represent a device malfunction.Given the limited information currently available for review, 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

After further review of additional information received the following: pma/510k, type of reportable event, if follow-up, what type, device manufacture date have been updated accordingly.No additional information will be forthcoming.

Manufacturer Narrative

Correction to (product code).

• Brand Name: 466P306AU
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7530277
• MDR Text Key: 108783099
• Report Number: 1016427-2018-01472
• Device Sequence Number: 1
• Product Code: DTK
• 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,Followup,Followup
• Report Date: 05/23/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15300996
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Disability
• Patient Age: 74 YR