MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Fracture (1260)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Thrombosis (2100)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

This report is a follow up report to mfr number 9616099-2016-00401 hat was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.The device has not been returned for analysis.Additionally, a device history record review could not be conducted as a sterile lot number was not received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient was implanted with a trap ease filter.The device subsequently malfunctioned by, inter alia, fracturing and causing clot development in and/or thrombosis of the filter.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.As reported in the medical record received on 03/20/2018 a perforation of filter struts(s) outside the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the inferior vena cava (ivc) and device unable to be retrieved, however there were no attempts made to retrieve the filter.The patient also suffered pain in the lower stomach that comes and goes, sometime the patient has problems urinating, and pain in both of the patient legs and hands are numb a lot.The patient has constant stress and anxiety about the broken filter that is stuck inside of the patient.

Manufacturer Narrative

As reported, the patient was implanted with a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The device subsequently malfunctioned by fracturing and causing clot development in and/or thrombosis of the filter.Per the medical record, there is a perforation of filter struts(s) outside the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the inferior vena cava (ivc) and device unable to be retrieved, however there were no documented attempts made to retrieve the filter.The patient also suffers intermittent pain in the lower stomach, problems urinating pain in the legs and numbness of the hands.The patient also has anxiety.The filter remains implanted; thus, unavailable for analysis.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 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 also 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, pain, numbness, and inability to urinate 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.

• Brand Name: TRAPEASE FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7439642
• MDR Text Key: 105780233
• Report Number: 1016427-2018-01392
• Device Sequence Number: 1
• Product Code: DQO
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 62 YR