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

Model Number 466P306X

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

The product was not returned for inspection.Manufacturing records (dhr) could not be performed as the product catalog and lot number were not available.Additional information will be submitted within 30 days upon receipt. .

Event Description

As reported by the legal team, the plaintiff underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to including, but not 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

As reported by the legal team, plaintiff underwent placement of the trapease vena cava filter on or about (b)(6) 2006.The filter subsequently malfunctioned and caused injury and damages to including, but not 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 shortness of breath.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.

Manufacturer Narrative

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

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) 2006.Per the patient profile form (ppf), the device was implanted due to a history of deep vein thrombosis (dvt.) the patient is reported to have tolerated the index procedure well.The filter subsequently malfunctioned and caused injury and damages to including, but not 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 ppf indicates that there was an attempted retrieval of the device although there have been no known documented attempts.The patient is reported to have experienced shortness of breath and 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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.The trapease device is not indicated for retrieval.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Chest pain, respiratory disorders and anxiety do not represent device malfunctions.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave.; miami lakes, FL 33014
• MDR Report Key: 6367849
• MDR Text Key: 68748856
• Report Number: 1016427-2017-00202
• Device Sequence Number: 1
• Product Code: DQO
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2018

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 Expiration Date: 09/30/2008
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1005664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/31/2017
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided; 12/07/2017; 01/19/2018
• Supplement Dates FDA Received: 03/16/2017; 01/07/2018; 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 38 YR