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

Catalog Number 466P306X

Device Problem Migration (4003)

Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135)

Event Date 07/05/2005

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation of the ivc filter struts, migration of the filter and blood clots/clotting.The indication for the filter placement has not been provided and 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.Blood clots, clotting and occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without images or procedural films for review, the reported filter migration and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the ivc including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation of the ivc filter struts, migration of the filter and blood clots/clotting.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, and pain and suffering, and other damages.

Manufacturer Narrative

Section b5: additional information received per the medical records indicate that the patient has a history of pulmonary embolus, hypoxia, chest pain and dyspnea.The filter was deployed via the patient's right femoral vein.It was distal to the renal veins.During the same procedure the patient had a left/right heart catheters placed, left ventriculogram and left lower extremity angiogram.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of the filter struts outside of the inferior vena cava (ivc), migration of the entire filter other than to the heart, blood clots, clotting and or occlusion of the ivc.The patient became aware of the reported events two years after the index procedure.A computed tomography (ct) scan performed of patient¿s trapease ivc filter revealed perforation of the ivc filter struts, migration of the filter and blood clots/clotting.These injuries have caused the patient to also experience emotional distress, mental anguish, anxiety and stress.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation of the ivc filter struts, migration of the filter and blood clots/clotting.The patient reports becoming aware of, perforation of the filter struts outside of the inferior vena cava (ivc), migration of the entire filter other than to the heart, blood clots, clotting and or occlusion of the ivc, approximately two years post implant.The events were noted on a computed tomography scan.The patient has also experienced emotional distress, mental anguish, anxiety and stress.According to the medical records the indication for the implant was pulmonary embolus, hypoxia, chest pain and dyspnea.A right heart catheterization was performed followed by placement of the ivc filter via the right femoral vein with deployment distal to the renal veins.A left heart catheterization, left ventriculogram, renal angiograms and aortogram with runoff was then performed.The cardiac catheterization revealed lesion of 60-70% in both the left anterior descending (lad), a diagonal branch and a 60% lesion in the right coronary artery (rca).Recommendation was to consider percutaneous coronary intervention of the rca and the lad/diagonal arteries.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.Blood clots, clotting and occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without images or procedural films for review, the reported filter migration and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the ivc including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 9373753
• MDR Text Key: 168052141
• Report Number: 1016427-2019-03591
• 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
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 J GUIDE WIRE; UNKNOWN 5 FRENCH AR MODIFIED CATHETER; UNKNOWN 5 FRENCH CATHETER; UNKNOWN 5 FRENCH PIGTAIL 145 DEGREE ANGLED CATHETE; UNKNOWN 5 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR