MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Pain (1994); Anxiety (2328)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of this report.

Event Description

As reported in the legal brief, the patient underwent placement of a trapease vena cava (ivc) filter.The following additional information received per the patient profile form (ppf) indicates the device was implanted due to a history of morbid obesity with deep vein thrombosis (dvt) involving both legs that was unresponsive to medication.The patient is reported to have experienced pulmonary embolism and dvt subsequent to filter placement, the device is embedded the vessel, pain in the upper left leg and is reported to continue to experience anxiety related to the device.The patient is reported to have tolerated the index procedure without incident.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The following additional information received per the patient profile form (ppf) indicates the device was implanted due to a history of morbid obesity with deep vein thrombosis (dvt) involving both legs that was unresponsive to medication.The patient is reported to have tolerated the index procedure without incident.The patient is reported to have experienced pulmonary embolism (pe) and dvt (deep vein thrombosis) subsequent to filter placement, the device is embedded the vessel, pain in the upper left leg and is reported to continue to experience anxiety related to the device.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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is 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 occur in as short a period as 12 days.Pe and dvt do not represent device malfunctions.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: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7170821
• MDR Text Key: 96583498
• Report Number: 1016427-2018-00970
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: 19196332
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/07/2018
• Supplement Dates Manufacturer Received: 01/27/2018
• Supplement Dates FDA Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GILDEWIREUNKNOWN FILTER INTRODUCER
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 43 YR