MAUDE Adverse Event Report: CORDIS CORPORATION FEMORAL 55CM KIT; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F230AF

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

Patient Problem Perforation of Vessels (2135)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of multiple episodes of gastrointestinal bleeding, iron deficiency anemia, esophageal and colonic angioectasia, chronic cramps and scleroderma.The patient presented to hospital with sharp right upper quadrant pain that radiated to the right shoulder and back and worsened with breathing.The patient reported difficulty breathing, chills, substernal chest pain, tachycardia and tachypnea.The patient was reported to have required admission to the intensive care unit.The following day, diagnostic testing revealed multiple bilateral lower lobe pe with significant esophageal dilation with fluid and anemia requiring intravenous iron administration and blood transfusions.Other diagnostic findings included gastric and colonic angioectasia, but no active bleeding.The patient again presented to hospital with shortness of breath and a positive fecal occult blood finding.Diagnostic testing revealed left lower extremity dvt and multiple bilateral pulmonary emboli (pe).The indication for the filter placement was reported to be as prophylaxis in the setting of poor surgical candidacy and a contraindication to anticoagulation therapy.The filter was implanted via the right common femoral vein and placed in an infrarenal position.Approximately five years nine months after the filter implantation, the patient became aware that the filter struts had perforated outside the wall of the inferior vena cava (ivc).The patient further reported having experienced lower extremity pain and poor circulation and twitches at the implant site location.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 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 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.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 pain, poor circulation and twitching 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.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter perforation.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.Information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt) in left popliteal, abdominal pain, atypical chest pain, dyspnea, multiple gastrointestinal bleeding, multiple bilateral pulmonary embolisms, angioectasias of esophagus and colon, iron deficiency anemia, chronic cramps, hypotension and scleroderma which includes telangiectasia.The patient was hospitalized two weeks prior for anemia.The patient presented at the hospital with sharp right upper quadrant pain that radiated to right shoulder and back.It worsened with breathing.She experienced difficulty breathing, some chills, tachycardia and tachypneic with significant pain.The patient was admitted to the intensive care unit.The next day she was shown to have multiple bilateral lower lobe pulmonary emboli with significant esophageal dilation with fluid.The patient was given three days of iv iron transfusions.Additional abnormal finding were angioectasias of gastric and colonic mucosa, but no active bleeding at that time.The patient presented to the hospital again with shortness of breath and positive fecal occult blood in the stool.She was found to have a left lower extremity dvt and multiple bilateral lower pulmonary artery embolisms.It was determined that a filter would be implanted.The filter was deployed via the patient's right common femoral vein using a modified seldinger technique.The filter was placed just below the renal veins.  information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported event approximately five years and nine months after the index procedure.The patient reported that they continue to experience leg pain, poor leg circulation and twitches at the implant site location.

• Brand Name: FEMORAL 55CM KIT
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12351182
• MDR Text Key: 267627769
• Report Number: 1016427-2021-05326
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032072899
• UDI-Public: 20705032072899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2021

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 Expiration Date: 01/31/2018
• Device Model Number: 466F230AF
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17189246
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/20/2021
• Date Device Manufactured: 02/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR