MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Break (1069)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135); No Code Available (3191)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient reported having experienced deep vein thrombosis (dvt), post-thrombotic syndrome, chest pain, shortness of breath and perforation of the inferior vena cava (ivc).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 ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported ivc perforation could not be confirmed and the exact cause could not be determined.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.These events do not represent a malfunction of the device.Post-thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Due to the nature of the complaint, the reported chest pain and shortness of breath experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, deep vein thrombosis (dvt) post-thrombotic syndrome, chest pain, shortness of breath and inferior vena cava (ivc) perforation.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, deep vein thrombosis (dvt) post-thrombotic syndrome, chest pain, shortness of breath and inferior vena cava (ivc) perforation.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the filter was indicated for deep vein thrombosis (dvt) and contraindication to anticoagulation.The patient's right upper chest and neck were prepped and draped, and a sterile right neck ultrasound demonstrated a patent right internal jugular vein normal in caliber and compressible without thrombosis.Under direct ultrasound guidance a micro puncture needle was introduced into the right internal jugular vein, followed by a micro puncture wire which was advanced into the superior vena cava (svc) under fluoroscopy guidance, followed by a micro puncture sheath.A guidewire was introduced through the sheath and into the right external iliac vein under fluoroscopic guidance.The trapease sheath dilator set was introduced over the guidewire into the right external iliac vein.The venacavogram performed demonstrated no thrombus in the right common iliac vein or ivc.The caval diameter was measured at 19mm; the iliac confluence was noted at the l4-5 level and the renal veins were visualized at the l1-2 level.The trapease ivc filter was then deployed under fluoroscopic guidance at the l3 level.The ivc gram was repeated demonstrating satisfactory deployment of the inferior vena cava filter above the iliac confluence and below the renal veins.No pneumothorax.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately two months after the filter implantation.The patient reports perforation of filter struts outside the ivc, blood clots, clotting and occlusion of the ivc.The patient further experienced psychological injuries such as stress, hair loss, fatigue, panic attacks, insomnia, in addition to mental anguish injuries such as fear, headaches, periodic paranoia and weight loss related to the filter.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of subdural hematoma and pulmonary embolism (pe).The indication for the filter placement was reported to be presence of deep vein thrombosis (dvt) with a contraindication to anticoagulation therapy.The filter was implanted via the right internal jugular vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well.Approximately two months after the filter implantation, the patient became aware that filter strut(s) had perforated outside the wall of the inferior vena cava (ivc) associated with blood clots, clotting and/or occlusion of the ivc.The patient indicated that they experienced dvt, post-thrombotic syndrome, chest pain and shortness of breath.The patient further reported having experienced psychological injuries that included mental anguish, stress, hair loss, fatigue, panic attacks, insomnia, fear, headaches, periodic paranoia and weight loss associated with the filter.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 pe via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Post-thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain and shortness of breath experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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.Should additional information become available, the file will be updated accordingly.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 10391641
• MDR Text Key: 202408447
• Report Number: 1016427-2020-04269
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17419669
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK J TIP GUIDEWIRE; UNK MICRO PUNCTURE NEEDLE; UNK WIRE, UNK SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR