MAUDE Adverse Event Report: CORDIS CORPORATION 466P306AU; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

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

Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135); No Code Available (3191)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.(b)(4).As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation of, and injury to the inferior vena cava (ivc) wall.The filter remains implanted; thus, unavailable for analysis.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.It was reported that there was perforation of, and injury to the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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.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 and injury to the inferior vena cava (ivc) wall.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

After further review of additional information received the following sections a2, b3, b5, b7, d1, d4, g4, g7, h2 and h6 have been updated according.Section b5: additional information received indicates that according to the patient profile form: the patient became aware of perforation of filter strut(s) outside the wall of the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc approximately six years and five months post implant (9/4/2109).The patient also reports experiencing 2 blood clots in the right lower extremity, shortness of breath, chest tightness, sharp pain in the leg that the filter was placed, neuropathy in the lower legs, insomnia and anxiety related to the filter.According to the implant record the indication for the filter implant was deep vein thrombosis (dvt) and leg pain.The filter was placed via the right common femoral vein and deployed at the level of l2, below the renal veins.The patient¿s medical history is noted for obesity, diabetes, sleep apnea, hypertension, chronic venous insufficiency, cervical spine degenerative disc disease, cervicalgia, hypercholesteremia, diabetic neuropathy, and acute on chronic kidney disease.Surgical history includes a hysterectomy, cholecystectomy and tonsillectomy.The patient was seen in the physician¿s office approximately three years and six months post implant (10/21/2016) for right leg swelling and pain.A venogram was performed in the office and demonstrated extensive dvt of the right lower extremity.The patient tolerated the procedure well and was to be admitted to a hospital.Approximately six years and five months post implant (9/4/2019) a computed tomography (ct) scan was performed to evaluate the ivc filter.The report noted that the ivc filter was infrarenal with no tilt seen, all struts are piercing through the ivc walls.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of obesity, diabetes, obstructive sleep apnea, hypertension, chronic venous insufficiency, cervical degenerative disc disease, cervicalgia, hypercholesterolemia, hyperlipidemia, diabetic neuropathy and acute on chronic kidney disease.The patient¿s surgical history included hysterectomy, cholecystectomy and tonsillectomy.The indication for the filter placement was reported to be deep vein thrombosis (dvt) and leg pain.The filter was implanted via the right common femoral vein and placed in an infrarenal position without complications.Approximately three and a half years after the filter implantation, the patient reported having experienced right leg swelling and pain.Diagnostic testing revealed extensive dvt of the right lower extremity.Approximately six years and five months after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that all of the filter struts had perforated through the wall of the inferior vena cava (ivc) with ivc injury without invasion of adjacent structures.There filter was in an infrarenal position with no evidence of tilting, stenosis or migration.Approximately six years after the filter implantation, the patient became aware that the filter was associated with blood clots, clotting and/or occlusion.The patient further reported having experienced shortness of breath, chest tightness, leg pain and neuropathy, an inability to walk distances, trouble standing for short periods, insomnia and anxiety 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 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 and injury 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.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 leg pain, shortness of breath, chest tightness, insomnia and neuropathy 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: 466P306AU
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10291048
• MDR Text Key: 199704314
• Report Number: 1016427-2020-04215
• 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,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: 466P306AU
• Device Lot Number: 15766861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR