MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Respiratory Distress (2045)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal team, plaintiff underwent placement of the trapease vena cava filter on or about (b)(6) 2012 in (b)(6).The filter subsequent malfunctioned and caused injury and damages including, but no limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require extensive medical care and treatment.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The trapease 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.As per the instructions for use (ifu), implantation of the trapease filter is contraindicated in patients with uncontrolled infectious disease.There are possible patient and pharmacological factors that may have contributed to the reported events of severe and constant chest pains and compromised respiratory system.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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

As reported by the legal team, plaintiff underwent placement of the trapease vena cava filter on or about (b)(6) 2012 in (b)(6).The filter subsequent malfunctioned and caused injury and damages including, but no limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the plaintiff suffered serious injuries and damages and will require extensive medical care and treatment.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter on or about (b)(6) 2012.The following additional information received per the patient profile form (ppf) indicates the device was implanted due to pulmonary emboli and extensive deep venous thrombosis (dvt), with contraindication to anticoagulation.The index procedure was reported to be a successful placement of the filter.The filter subsequently malfunctioned and caused injury and damages including, but no limited to, severe and constant chest pains and compromised respiratory system.As a direct and proximate result of these malfunctions, the patient suffered serious injuries and damages and will require extensive medical care and treatment.The patient is reported to have experienced shortness of breath and the patient continues to experience anxiety related to the device.The filter remains implanted; thus, unavailable for analysis.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 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.Anxiety, chest pain, respiratory disorder and shortness of breath do not represent device malfunctions and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient comorbidities, 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.

Manufacturer Narrative

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

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6358219
• MDR Text Key: 68349325
• Report Number: 1016427-2017-00191
• 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,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15622584
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2017
• Date Manufacturer Received: 01/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR