MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAV FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problems Entrapment of Device (1212); Retraction Problem (1536)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

Information is pending and will be submitted in a follow up report when received.

Event Description

As reported in the legal brief, an unspecified period after a trapease vena cav filter was implanted, the filter subsequently malfunctioned and caused injury, including, filter is embedded and unable to be retrieved.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

It was reported that a patient that had a trapease vena cava filter implanted experienced embedment of the filter and it can¿t be retrieved.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.There is currently no additional information available for review.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.Following implant, 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 lead to explantation problems after as short a period as 12 days.Given the limited information currently available for review, 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 received per the medical records indicate that the patient has a history of respiratory failure, large pulmonary embolus and acute deep venous thrombosis.The filter was deployed via the patient's right common femoral vein using ultrasound guidance.There were two flow defects on the left side of the vena cava, most consistent with either large lumbar veins or possibly multiple renal veins.Given the overall appearance, the filter was placed below the left-sided flow defects to ensure non obstruction of the left renal vein.The filter was placed satisfactorily into the infrarenal position and there were no immediate complications.  additional information received per the patient profile form (ppf) states that the filter is embedded in the wall of the inferior vena cava (ivc) and is unable to be retrieved.The patient continues to experience emotional distress, mental anguish, anxiety and stress.As reported, after a trapease inferior vena cava (ivc) filter was implanted, the filter subsequently malfunctioned and caused injury, including, filter is embedded and unable to be retrieved.Per the medical records, history includes respiratory failure, large pulmonary embolus and acute deep venous thrombosis.The filter was deployed via the patient's right common femoral vein using ultrasound guidance.There were two flow defects on the left side of the vena cava, most consistent with either large lumbar veins or possibly multiple renal veins.Given the overall appearance, the filter was placed below the left-sided flow defects to ensure non obstruction of the left renal vein.The filter was placed satisfactorily into the infrarenal position and there were no immediate complications.Per the patient profile form (ppf), the patient reports the filter is embedded in the wall of the inferior vena cava (ivc) and is unable to be retrieved.The patient continues to experience emotional distress, mental anguish, anxiety and stress.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.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.Corrected data: the previously reported code for perforation has been corrected to the code for device embedded in vessel.

• Brand Name: UNKNOWN TRAPEASE VENA CAV FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8473891
• MDR Text Key: 140640948
• Report Number: 1016427-2019-02672
• Device Sequence Number: 1
• Product Code: DTK
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Date Manufacturer Received: 04/30/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.018 GUIDE WIRE; UNKNOWN 5 FRENCH SHEATH; UNKNOWN MICROPUNCTURE SHEATH; UNKNOWN TENNIS RACKET CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR