MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466P306AU
Health Effect - Clinical Codes	Perforation (2001); Perforation of Vessels (2135); Stenosis (2263)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and stenosis.The patient became aware of the reported events approximately ten months post implant.The indication for the filter implant has not been provided and there is currently no additional information available for review.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 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 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.Stenosis, an abnormal narrowing of a vessel, and does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.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 notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant imaging available for review, the reported filter perforation could not be confirmed or further clarified.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.Please note that this is the initial report for this product.
Event or Problem Description
As reported by the legal brief, 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 perforation and stenosis.The patient became aware of the reported events approximately ten months after the index procedure.
Event or Problem Description
Additional information received per the medical records indicate that the patient has a history of friedreich¿s ataxia, hypertension, neuropathy, right lower lobe pneumonia, chest pain, shortness of breath.The indication for the filter placement was bilateral pulmonary emboli (pe) and left lower extremity deep vein thrombosis (dvt) with a contraindication to anticoagulation due to a history of falling related to ataxia.The filter was placed via the right internal jugular vein and deployed in the infrarenal inferior vena cava (ivc).Approximately ten months post implant a computed tomography (ct) scan was performed to evaluate the filter.Results of the scan noted that the filter is in place with slight protrusion of filter struts through the ivc wall at 8, 12 and 2 o¿clock and mild ivc stenosis at and below the inferior tip of the ivc filter.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut outside the inferior vena cava (ivc) and stenosis.The patient also reported fear that the filter might cause further damage.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: a2, a4, a5, b3, b4, b5, b6, b7, d1, d4, g2, g3, g6, h1, h2, h4 and h6.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and stenosis.The patient became aware of the reported events approximately ten months post implant.According to the medical record the patient had a history of friedreich¿s ataxia, hypertension, neuropathy, right lower lobe pneumonia, chest pain, shortness of breath.The indication for the filter placement was bilateral pulmonary emboli (pe) and left lower extremity deep vein thrombosis (dvt) with a contraindication to anticoagulation due to a history of falling related to ataxia.The filter was placed via the right internal jugular vein and deployed in the infrarenal inferior vena cava (ivc).Approximately ten months post implant a computed tomography (ct) scan was performed to evaluate the filter.Results of the scan noted that the filter is in place with slight protrusion of filter struts through the ivc wall at 8, 12 and 2 o¿clock and mild ivc stenosis at and below the inferior tip of the ivc filter.The product remains implanted and unavailable 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 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 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.Stenosis, an abnormal narrowing of a vessel, and does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.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 notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant imaging available for review, the reported filter perforation could not be confirmed or further clarified.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15147801
• Report Number: 9616099-2022-05873
• Device Sequence Number: 17508969
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17770136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: Black Or African American