MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER; THROMBECTOMY SYSTEMS (DTK)

Catalog Number 466FXXXX

Device Problem Difficult to Remove (1528)

Patient Problems Pelvic Inflammatory Disease (2000); Thrombosis (2100); Abdominal Cramps (2543)

Event Date 10/10/2011

Event Type  Injury  

Event Description

A voluntary medwatch was submitted by a patient reporting the following.On (b)(6) 2011, she had an optease filter implanted in the inferior vena cava.There was an attempt to remove the filter in 2011, however, the procedure ¿failed¿.The physician reported that if he tried to pull it out it would have ¿ripped the tissue¿.In 2012, the patient started complaining of right and left abdominal pain.After several ct scans with physicians visits, it was noted that the filter had ¿completely closed my inferior vena cava¿.On an unknown date, the patient went to the operating room (or) and the physician tried to take the filter, by laser, but he could not ¿get it out¿.The patient asked the physician to try again because ¿my inferior vena cava was closed and the pain on the left side was awful¿.In 2014, the doctor was successful.After the filter was removed, they put in a stent for the blood to flow and embolization on the left side was performed.

Manufacturer Narrative

Please note date of event is an approximate date, the exact date of the event is unknown.The voluntary medwatch (report # is mw5039427) was submitted by the patient.The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Please note that event date and patient codes have been updated based on additional information.Per medical records received, on (b)(6) 2011, the patient underwent ivc filter placement (optease) due to history of pulmonary embolic disease.The right common femoral vein was assessed.After placing an introducer sheath, injection was made in the inferior vena cava for the purpose of identifying renal vein location.Selective catherization was also utilized to identify the renal veins.After repositioning of the sheath, an optease ivc filter was deployed.The patient tolerated the procedure without difficulty.On (b)(6) 2011, there was an attempt to remove the filter however the physician failed to remove the optease.The patient underwent a diagnostic laparoscopy in (b)(6) 2014, during which pictures of large left lower quadrant varicosities were taken.Per the radiologist consult on (b)(6) 2015, the lower inferior vena cava shows signs of chronic occlusion related to the filter.Both common iliac veins appear normal.The patient was diagnosed with pelvic congestion syndrome due to pelvic varices that have arisen as a collateral circulation to the left ovarian vein in the face of filter-related chronic inferior vena cava occlusion.On (b)(6) 2014, the patient underwent the ivc filter removal, inferior vena cava stent placement.A 14f laser sheath was obtained and passed through the 18 f sheath over the wire loop.The neck of the filter was easily sheathed.When resistance was met at the body of the filter, laser activation was performed to circumferentially ablate the adherent tissue.In this manner, the filter was slowly, yet completely brought into the 18f sheath.The filter was pulled from the external end of the sheath and examined on the table, revealing residual adherent tissue but no fracture of the filter parts.All parts of the filter were confirmed to be present.Complaint conclusion: as reported via a voluntary med watch, retrieval difficulty from the vessel wall was experienced.A year later the patient experienced abdominal pain.Thrombus was noted and the patient was diagnosed with pelvic congestion.The filter was eventually removed with excimer laser-mediated tissue ablation of strongly adherent tissue.Per medical records received, on (b)(6) 2011 the patient underwent ivc filter placement (optease) due to history of pulmonary embolic disease.The right common femoral vein was assessed.After placing an introducer sheath, injection was made in the inferior vena cava for the purpose of identifying renal vein location.Selective catherization was also utilized to identify the renal veins.After repositioning of the sheath, an optease ivc filter was deployed.The patient tolerated the procedure without difficulty.The filter was to be removed within eight weeks, however it was indicated to the patient that ¿they forgot i had one.¿ after the patient questioned when the filter would be removed, an attempt was made on (b)(6) 2011; however, the physician failed to remove the optease as it would have ¿ripped the tissue.¿ per the submitted report, in 2012, the patient began to experience right and left abdominal pain.After several ct scans and physician visits, the patient underwent a diagnostic laparoscopy in (b)(6) 2014, during which pictures of large left lower quadrant varicosities were taken.Per the radiologist consult on (b)(6) 2014, the lower inferior vena cava showed signs of chronic occlusion related to the filter.Both common iliac veins appeared normal.The patient was diagnosed with pelvic congestion syndrome due to pelvic varices that arose as a collateral circulation to the left ovarian vein in the face of filter-related chronic inferior vena cava occlusion.On (b)(6) 2014, the patient underwent the ivc filter removal and inferior vena cava stent placement.A 14f laser sheath was obtained and passed through the 18 f sheath over the wire loop.The neck of the filter was easily sheathed.When resistance was met at the body of the filter, laser activation was performed to circumferentially ablate the adherent tissue.In this manner, the filter was slowly, yet completely brought into the 18f sheath.The filter was pulled from the external end of the sheath and examined on the table, revealing residual adherent tissue but no fracture of the filter parts.All parts of the filter were confirmed to be present.The inferior vena cava was revascularized using a stent-graft with a good result.Pelvic varices, secondary to pelvic congestion, were treated with retrograde balloon-occluded obliteration using a sclerosant foam.The patient was admitted to the recovery room for overnight monitoring and was to be discharged on anticoagulation medications.The device was not returned for analysis nor was a sterile lot number provided in order to conduct a device history review.Vessel occlusion/thrombosis is a well-known complication of ivc filters and is listed in the instructions for use which also notes that, where practicable, a retrievable filter should be removed if a conventional course of anticoagulation therapy can be started, or if the underlying reason for indication is resolved.Obstructing anatomic anomalies may also lead to secondary pelvic congestion syndrome.In patients with a retroaortic left renal vein, there may be obstruction of the left ovarian vein leading to symptomatic pelvic varices.Pain related to symptomatic pelvic varices is usually experienced in the lower abdomen and/or lower back.The retrieval difficulty experienced by the costumer was most likely related to the length of time the filter was deployed in the patient.The ifu states that the indication is for up to 23 days.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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Without a sterile lot number or return of the device, there is no indication that this event is related to the design and manufacturing process of the device; therefore, no corrective action will be taken at this time.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4858694
• MDR Text Key: 5875278
• Report Number: 9616099-2015-00241
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

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: Other
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention