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

Catalog Number 466P306X

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

Patient Problem Abdominal Pain (1685)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of a pulmonary embolus and a pulmonary arteriogram.The device was implanted into the patient¿s right common femoral vein.The device was positively identified by the patient¿s medical records.On or about thirteen years and three months later, the patient had a scan done on his abdomen for complaints of pain.The scan noted the presence of the inferior vena cava (ivc) filter in the region.As of the present, the patient is still implanted with the implanted device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter 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.The product was not returned for analysis.Additionally, as the sterile lot number was not available, the device history record (dhr) review could not be performed.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.Abdominal pain does not represent a device malfunction.Such an event may be related to other comorbidities and not necessarily related to the implantation of the filter.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device.Therefore, no corrective action will be taken.

Event Description

As reported by the legal brief, the patient on or about (b)(6) 2003 underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of a pulmonary embolus and a pulmonary arteriogram.The device was implanted into the patient¿s right common femoral vein.The device was positively identified by the patient¿s medical records.On or about (b)(6) 2016, the patient had a scan done on his abdomen for complaints of pain.The scan noted the presence of the inferior vena cava (ivc) filter in the region.As of the present, the patient is still implanted with the implanted device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter 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.

Manufacturer Narrative

According to the patient profile form (ppf), the findings in the procedural notes from a pulmonary angiogram and ivc filter implant indicated a small peripheral filling defect anteromedial segment of left lower lobe compatible with probable small acute pulmonary embolus and successful, uncomplicated deployment of an ivc filter in the infrarenal area of the ivc.Additional information received on the patient profile form (ppf) alleges other injuries to be determined by future scans.The patient indicated that there is a fear of the filter failing and pieces breaking off and damaging the lungs or heart and the device failing while asleep or driving alone in the car.The patient is also reported to be suffering from mental anguish.The medical records indicated that the filter was placed for status post gunshot wound with paraplegia and suspected pulmonary embolus.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient underwent a procedure to implant a trapease permanent vena cava filter.Additional information received on the patient profile form (ppf) indicated that the patient is experiencing anxiety related to the device.The medical records indicated that the filter was placed for status post gunshot wound with paraplegia and suspected pulmonary embolus.The anatomical location of the gunshot wound has not been provided.The findings in the procedural notes from a pulmonary angiogram and ivc filter implant indicated a small peripheral filling defect anteromedial segment of left lower lobe compatible with probable small acute pulmonary embolus and successful, uncomplicated deployment of an ivc filter in the infrarenal area of the ivc.There is currently no additional information available.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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 and abdominal pain do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such 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; EI
• MDR Report Key: 6875608
• MDR Text Key: 86601699
• Report Number: 1016427-2017-00593
• 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,Followup
• Report Date: 04/06/2018

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: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 02/06/2018; 02/06/2018
• Supplement Dates FDA Received: 03/29/2018; 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 8 FRENCH SHEATH UNKNOWN 8 FRENCH CAT
• Patient Outcome(s): Life Threatening; Required Intervention