MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

Device Problem Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of left lower extremity deep vein thrombosis (dvt), endometrial cancer, congestive heart failure, raynaud¿ s disease, osteoarthritis, asthma, leaking mitral valve, aortic insufficiency, gastroesophageal reflux disease, hiatal hernia, irritable bowel syndrome, sleep apnea, atrial fibrillation, chronic obstructive pulmonary disease and hypoglycemia.In addition, the patient was noted to have a surgical history that included breast lumpectomies, right knew arthroscopy, right wrist fusion and left knee replacement.The indication for the filter placement was reported to be the patient¿s recent gynecological surgery and difficulties associated with anticoagulation therapy during this post-operative period.The filter was implanted via the right common femoral vein and placed in an infrarenal position.Six days after the filter implantation, the patient underwent a total hysterectomy, bilateral salpingo-oophorectomy, bilateral para-aortic and pelvic node dissection and peritoneal washings.Approximately eight months after the filter implantation, the patient underwent an excision of vaginal nodule, as a possible recurrence of endometrial cancer.Approximately six weeks later, the patient learned that these biopsy results had been positive and was treated with radiation, chemotherapy and the placement of a vaginal cuff.Approximately five years and seven months after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that the filter had tilted, and that the filter had perforated the anterior wall of the inferior vena cava (ivc) and was impinging on the overlying bowel.The filter struts were also reported to be tenting the ivc wall with early perforation and erosion suspected.Approximately six and a half years after the filter implantation, the patient presented to hospital with diarrhea, nausea, vomiting and mild lower abdominal cramping.A ct scan revealed moderate dilation of the cecum but no obstructing lesion suggestive for abnormal absorption.The patient was diagnosed with gastroenteritis and discharged home the same day.The patient further reported having experienced mental anguish 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 optease retrievable 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 filter tilt and ivc perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.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 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.

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: physical and emotional damages from tilt and perforation of the filter.The proximal filter apex contacting and actually perforation the anterior wall of the ivc and impinging on overlying bowel.All 6 primary struts tent the ivc wall with early perforation and erosion suspected medially, laterally and anteriorly.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.The following additional information was received per implant records: the filter was placed prior to gynecology oncology surgery as it would be difficult to continue anticoagulation during the perioperative time, in a patient with a history of left lower extremity deep vein thrombosis (dvt).The filter was placed via the right common femoral vein and deployed above the caval bifurcation and just below the area of the renal veins.The medical history listed in the record is notable for endometrial cancer, congestive heart failure, raynaud¿ s disease, osteoarthritis, asthma, leaking mitral valve, aortic insufficiency, gastroesophageal reflux disease, hiatal hernia, irritable bowel syndrome, sleep apnea, atrial fibrillation, chronic obstructive pulmonary disease, hypoglycemia, and dvt.Surgical history was noted as left breast lumpectomy times 2, right knee arthroscopy, right wrist fusion and left knee replacement.The following additional information was received per medical records: approximately 6 days post filter implantation, the patient underwent a total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, bilateral para-aortic and pelvic node dissection and peritoneal washings.Approximately eight months later, the patient underwent an excision of vaginal nodule, as a possible recurrence of endometrial cancer.Approximately 6 weeks post excision of vaginal nodule, the recurrence was positive and the patient underwent placement of a subclavian portacath.Following the portacath placement, a course of radiation, chemotherapy and placement of a vaginal cuff was completed.The following additional information was received per medical records: a ct scan of the abdomen performed approximately 5 years and 7 months post filter implantation revealed: the patient had a history of left lower extremity deep vein thrombosis, was on anticoagulant therapy, and has endometrial cancer.Suspension of anticoagulant treatment was necessary prior to a scheduled gynecological surgery in 2011.The review of the images noted that the filter it tilted anteriorly with the proximal filter apex perforating the anterior wall of the ivc and impinging on overlying bowel.All 6 primary struts tent the ivc wall with early perforation and erosion suspected medially, laterally and anteriorly.The following additional information was received per medical records: the patient presented to the hospital with complaints of diarrhea, nausea, vomiting and mild lower abdominal cramping approximately 6 years and 6 months post filter implantation.The patient was discharged the same day with a diagnosis of gastroenteritis.A ct scan performed during this visit noted moderate dilation of the cecum but no obstructing lesion and fluid throughout much of the colon indicating abnormal resorption.The following additional information was received per patient profile form (ppf): the patient became aware of the reported events approximately 6 years and 6 months post implantation.The patient reports perforation of filter strut(s) outside the ivc and filter tilt.The patient also reports abdominal pain and anxiety.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10122523
• MDR Text Key: 194806080
• Report Number: 1016427-2020-04007
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15473247
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 112