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

Model Number 466P306AU

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.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 fracture, perforation, perforation abutting an adjacent organ and tilt.The patient reported becoming aware of filter fracture within the inferior vena cava (ivc), perforation of filter strut(s) outside the ivc, perforation abutting an organ and tilt of the filter approximately thirteen years and five months post implant.The patient also reported anxiety related to the filter.According to the implant record the indication for the filter placement was pulmonary embolus and inability to anticoagulated due to the development of a gastrointestinal bleed while on heparin.The patient was also noted to be obese.Due to the patient¿s size and inability to palpate a femoral pulse a cut down approach was made and the filter was placed via the right saphenous vein and deployed with the tip of the filter at the top level of l3.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 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.The instructions for use (ifu) states filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Clinical factors that may have influenced the event include patient and/or vessel characteristics.Without procedural films or images for review the reported event(s) could not be confirmed or further clarified.Anxiety does 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.Please note that this is the initial/final report for this product.

Event 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 fracture, perforation, perforation abutting an adjacent organ and tilt.Additional information received per the medical records indicate that the patient has a history of shortness of breath and pulmonary embolus with inability to fully anticoagulate.It was noted that the patient developed gastrointestinal bleeding after use of heparin.The filter was deployed via the patient's right groin.The filter was inserted such that the top of the filter was positioned at the top of the l3 level.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture within the inferior vena cava (ivc), perforation of filter strut(s) outside the ivc, perforation abutting an organ and tilt of the filter.The patient continues to experience anxiety and worry.The patient became aware of the reported events thirteen years and five months after the index procedure.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: 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 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10240706
• MDR Text Key: 197844277
• Report Number: 1016427-2020-04149
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2008
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0805074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Date Device Manufactured: 08/10/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN DILATOR; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 43 YR
• Patient Weight: 181