MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF BRACH 90CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Anxiety (2328)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter.Per the medical records, the patient was admitted to the hospital for left common femoral deep vein thrombosis (dvt).While hospitalized, irregular vaginal bleeding was noted.The patient was diagnosed with adnexal and abdominal mass; that was suspicious of cancer.The indication for the filter placement was pulmonary embolism (pe).Insertion of the trapease filter was done prior to surgical resection for the identified abdominal mass.The ivc filter device was positively identified by implant date in medical records and the manufacturer-issued patient implant identification card.As the result of the trapease filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body.Per the patient profile form (ppf), the ivc filter has been unable to be retrieved; although there is no documentation of a removal attempt.The patient also reports to be suffering from anxiety.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.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.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.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent inferior vena cava filter.Per the medical records, the patient was admitted to the hospital for left common femoral deep vein thrombosis (dvt).While hospitalized, irregular vaginal bleeding was noted.The patient was diagnosed with adnexal and abdominal mass; that was suspicious of cancer.The indication for the filter placement was pulmonary embolism (pe).Insertion of the trapease filter was done prior to surgical resection for the identified abdominal mass.The ivc filter device was positively identified by implant date in medical records and the manufacturer-issued patient implant identification card.As the result of the trapease filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body.Per the patient profile form (ppf), the ivc filter has been unable to be retrieved; although there is no documentation of a removal attempt.The patient also reports to be suffering from anxiety.The filter remains implanted; thus, unavailable for analysis.

• Brand Name: TRAPEASE PVCF BRACH 90CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; cahir road ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7374173
• MDR Text Key: 103586808
• Report Number: 1016427-2018-01284
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

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: 10/31/2013
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: 15289753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/31/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 03/27/2018
• Date Device Manufactured: 01/06/2011
• 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
• Treatment: UNKNOWN SCALPELUNKNOWN METZENBAUM SCISSORSUNKN
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR