MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Fracture (1260)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Additional information is pending and will be submitted in a follow up report when received.

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 and fracture.

Manufacturer Narrative

According to the information received in the patient profile form (ppf), the patient became aware of the reported events twelve years and three months post implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture, and perforation of filter strut(s) outside the ivc.The patient also reports anxiety and worry that the filter has fractured within the vena cava and perforated outside of it.According to the medical records, the patient had a preoperative diagnosis of retroperitoneal hematoma, pulmonary embolism, and contraindications to anticoagulation and poor intravenous access.During the implant procedure, venipuncture of the femoral vein was performed without difficulty followed by a guidewire sheath and introducer.Inferior venacavogram was performed, not clearly demonstrating the origin of the renal veins.The filter was then placed clearly from the body at 12-3 level at the apex.The patient tolerated the procedure well.

Manufacturer Narrative

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was retroperitoneal hematoma, pulmonary embolism, and contraindications to anticoagulation with poor intravenous access.During the implant procedure, venacavogram was performed, and the filter was then placed with the apex at l2-3 level at the apex.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation and fracture.Per the patient profile form (ppf), the patient reports fracture, and perforation of filter strut(s) outside the ivc.The patient also reports anxiety.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.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Anxiety does 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.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9511742
• MDR Text Key: 176212931
• Report Number: 1016427-2019-03697
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR