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

Model Number 466P306AU

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

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 of all filter struts outside the wall of the ivc and into surrounding tissues/organs.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 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.The timing and mechanism of the perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without post implant images available for review the reported perforation into surrounding tissue could not be confirmed or further clarified.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of all filter struts outside the wall of the ivc and into surrounding tissues/organs.As a result of the malfunction, 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, pain and suffering, and other damages.

Manufacturer Narrative

Additional information: section a2 (age at the time of event, date of birth) section b3 (event date) section b4 (event description) section b7 (relevant medical history) section d1 (brand name) section d4 (model, catalog, lot number) section d11 (concomitant medical products: 5f pigtail catheter, cobra 2 catheter) section g4 (date received by the manufacturer) section h4 (manufacturing date) section h6 (evaluation codes: addition of patient code 1987 and device codes 2993 and 816) complaint conclusion: 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 of all filter struts outside the wall of the ivc and into surrounding tissues/organs.The patient reported becoming aware of perforation of filter strut(s) outside the ivc, perforation of filter strut(s) into organs, approximately 12 years and 5 months post implant.The patient also reports experiencing erectile dysfunction, swelling and fatigue.According to the medical records the patient presented with a right thalamic hematoma and subsequently developed pulmonary embolic (pe) disease based on a computed tomography (ct) pulmonary angiogram study.The indication for the filter implant was pe and a contraindication to anticoagulation.The filter was placed via the right femoral vein and deployed at the l2 level, after identifying the location of the renal veins, without complication.Approximately 11 years and 9 months post implant, a ct scan was performed.The scan identified the filter at the l2 level and determined all struts perforated the wall of the ivc with one strut in contact with the bowel.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.The timing and mechanism of the perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without post implant images available for review the reported perforation into surrounding tissue could not be confirmed or further clarified.Due to the nature of the complaint the reported swelling, fatigue and erectile dysfunction could not be further clarified, nor a cause determined.These events do not represent a device malfunction and may be related to underlying patient specific issues.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of all filter struts outside the wall of the ivc and into surrounding tissues/organs.As a result of the malfunction, 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, pain and suffering, and other damages.The following additional information was received per medical records: the patient presented with a right thalamic hematoma and has subsequently developed pulmonary embolic disease based on a ctpa study.The right femoral vein was accessed, contrast injected and the renal/femoral veins were identified via cavagram.The trapease filter was deployed at the l2 level without complication.Approximately 11 years and 9 months post implantation, a ct scan was performed.The scan identified the filter at the l2 level and determined all struts perforated the wall of the ivc with one strut in contact with the bowel.The following additional information was received per patient profile form (ppf): the patient became aware of the reported events approximately 12 years and 5 months post implantation.The patient reports perforation of filter strut(s) outside the ivc, perforation of filter strut(s) into organs.The patient also reports suffering from erectile dysfunction, swelling and fatigue.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9833123
• MDR Text Key: 188509300
• Report Number: 1016427-2020-03925
• 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
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0407168
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR