MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Unspecified Infection (1930); Tricuspid Insufficiency (2111); Perforation of Vessels (2135); No Code Available (3191)

Event Date 04/07/2011

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown; stated to be on or about (b)(6) 2008.The ivc filter was said to be removed via cardiotomy on an unknown date.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: migration of the ivc filter into the right ventricular cavity.The ivc filter embolized to the right ventricular and caused damage to the patient's tricuspid valve.Cardiotomy was done for removal of the ivc filter.The patient's tricuspid valve was replaced due to damage caused by the filter.Sternal infection after the cardiac surgery resulting in a second hospitalization.Struts of the filter have perforated the wall of the 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 optease 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 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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (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 inferior vena cava 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.Valve replacement, while not specifically listed in the ifu, is a known potential adverse event associated to ivc filters, specifically related to the potential event of migration, as happened in this case.Infection is a well known potential event associated to all invasive procedures and may be related to the surgical technique or patient specific issues rather than the removed ivc filter.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.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: migration of the ivc filter into the right ventricular cavity.The ivc filter embolized to the right ventricular and caused damage to the patient's tricuspid valve.Cardiotomy for removal of the ivc filter.The patient's tricuspid valve was replaced due to damage caused by the embolized filter.Sternal infection after the cardiac surgery resulting in a second hospitalization.Struts of the filter have perforated the wall of the ivc.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to, migration of the inferior vena cava (ivc) filter into the right ventricular cavity.The ivc filter embolized to the right ventricular and caused damage to the patient's tricuspid valve.Cardiotomy for removal of the ivc filter.The patient's tricuspid valve was replaced due to damage caused by the embolized filter.Sternal infection after the cardiac surgery resulting in a second hospitalization.Struts of the filter have perforated the wall of the ivc.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.Per the medical records, the clinical history included sleep apnea, gastroesophageal reflux disease, weight bearing arthritis, deep vein thrombosis (dvt) patent foramen ovale with transient ischemic attack (tia), left knee replacement, morbid obesity and thrombophlebitis.According to the implant records, the patient underwent a laparoscopic surgical gastric restrictive procedure, with gastric bypass and roux-en-y gastroenterostomy with hernia repair and placement of an optease ivc filter.The filter placement was indicated due to the high risk for dvt, resulting in pulmonary embolism (pe).Using ultrasonic guidance, the right internal jugular vein was identified and punctured.Under fluoroscopic guidance, a vena cavogram was performed, which appeared to delineate the renal vasculature with the right renal vein at the level of l2-l3, but because of the body habitus could not be well delineated.The optease filter was placed below this renal vein, and a post-deployment fluoroscopic picture was taken to assure proper placement.The laparoscopic gastric bypass was completed next.According to the information received in the redacted-amended patient profile form (ppf), the patient became aware of the reported events approximately ten years post implantation.The patient reports migration of the entire filter to the heart; filter embedded other than in wall of the ivc, in addition to median sternotomy and cardiotomy for removal of the ivc filter from the right ventricular cavity, sternal infection after cardiac surgery, the filter embolized into the right ventricle and caused damage to the tricuspid valve resulting in tricuspid valve replacement.The patient further experienced anxiety related to the filter.Per the medical records provided, approximately two years and seven months after the filter was implanted, the patient underwent open cardiac surgery to remove the impacted ivc filter from the right heart ventricle, closure of a patent foramen ovale and replacement of the tricuspid valve.Post-operative blood sugar elevation was noted.Approximately twelve days post removal procedure, the patient was admitted for a superficial sternal wound infection post open chest surgical removal of the optease filter and tricuspid valve replacement for tricuspid regurgitation.Sternal wound drainage was done under anesthesia.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of sleep apnea, gastroesophageal reflux disease, weight-bearing arthritis, recurrent deep vein thrombosis (dvt), patent foramen ovale (pfo) with transient ischemic attack (tia), subvalvular aortic stenosis, left knee replacement, morbid obesity and thrombophlebitis.The indication for the filter placement was reported to be the patient¿s high risk for dvt and resultant pulmonary embolism (pe).The filter was implanted via the right internal jugular vein.Because of the patient¿s obesity, the level of the renal veins could not be clearly delineated.The filter was placed below the right renal vein.The patient then underwent a laparoscopic gastric restrictive surgery with gastric bypass and rouen-en-y gastroenterostomy with abdominal hernia repair.Approximately two years and seven months after the filter implantation, the patient became aware that the entire filter had migrated into the right ventricular cavity causing damage to the patient¿s tricuspid valve.The filter was further noted to be embedded and had perforated the inferior vena cava (ivc).The patient underwent surgical removal of the filter via sternotomy in conjunction with tricuspid valve repair and closure of the pfo.The patient then developed a superficial sternal infection and was re-admitted to hospital and was treated with sternal wound drainage.The patient further reported having experienced anxiety and mental anguish associated with the filter.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 optease retrievable 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.Without images or procedural films for review, the reported filter migration, device embedment and ivc perforation events 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 instruction for use (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.The predominant concern for embedding within 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.The optease retrievable vena cava filter is indicated for retrieval up to 23 days post-implantation.Following this period of time, and as early as twelve days, there is potential for endothelialization around the filter struts.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.Due to the nature of the complaint, the reported tricuspid valve repair, sternotomy and sternal infection 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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9298311
• MDR Text Key: 185242001
• Report Number: 1016427-2019-03533
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 8 FCATHETER; UNK WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 39 YR
• Patient Weight: 241