MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown; if received it will be provided.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 tilt of the inferior vena cava (ivc) filter and device unable to be retrieved.The indication for the filter placement, procedural details and medical history have not been provided and there is 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.The trapease ivc filter is intended for permanent placement.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Without procedural films or post implant imaging and the very limited information available for review, the reported filter events 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.

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 including, but not limited to: tilt of the ivc filter and device unable to be retrieved.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, b7, d11, g3, g4, g7, h1, h2 and h6.As reported, the patient underwent placement of a trapease inferior vena cava filter.Per the medical records, history includes super obesity, marked venous insufficiency, planned gastric bypass.The filter was placed within 1 cm of the lower edge of the renal veins.The patient was in satisfactory condition after the procedure.The filter subsequently malfunctioned and caused injury and damages including, but not limited to tilt of the ivc and the device is unable to be retrieved.A ct scan, done thirteen years and eight months post implant, indicate the filter was tilted 10 degrees.The apex of the filter touches the inferior vena cava (ivc) wall.The apex was less than 2 cm below the most inferior vena cava.There are no fractured or bent struts.Per the patient profile form (ppf), the patient reports filter tilt, filter embedded in wall of the ivc and the device was unable to be retrieved, pain (chronic back, abdominal pain, chest pain and discomfort at the site of the filter) and mental anguish.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Anxiety and pain do 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of super morbidity, marked venous insufficiency, planned gastric bypass with high risk for deep venous thrombosis and pulmonary embolism.The operative report states that there were multiple attempts made to access the patient's right femoral vein.A smart needle was used to gain access.The filter was placed within 1 cm of the lower edge of the renal veins.The patient was in satisfactory condition after the procedure.The results of computed tomography (ct) scans done approximately thirteen years and eight months after the index procedure indicate that the filter was tilted 10 degrees.The apex of the filter touches the inferior vena cava (ivc) wall.The apex was less than 2 cm below the most inferior vena cava.There are no fractured or bent struts.  additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, filter embedded in wall of the ivc and the device was unable to be retrieved, pain (chronic back, abdominal pain, chest pain and discomfort at the site of the filter) and mental anguish.The patient became aware of the reported events approximately thirteen years and eight months after the index procedure.The form noted that there have no attempts to remove the device.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10214397
• MDR Text Key: 197335046
• Report Number: 1016427-2020-04116
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRAPEASE DILATOR; TRAPEASE SHEATH; UNKNOWN GUIDE WIRE; UNKNOWN SMALL 5 FRENCH INTRODUCER
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR