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U.S. Department of Health and Human Services

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

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Occlusion (1984); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135); Vomiting (2144); Neck Pain (2433)
Event Date 04/04/2017
Event Type  Injury  
Manufacturer Narrative

As reported by the legal team, a patient underwent placement of a cordis optease vena cava filter on or about (b)(6) 2015. The physician was responsible for providing informed consent and placing the device. Upon the device subsequently malfunctioned by, inter alia, migrating, tilting and perforating the vena cava, and by being thrombogenic. Plaintiff then underwent several failed medical procedures to retrieve the defective device, including one on or about (b)(6) 2015. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not 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. Thrombosis does not represent a device malfunction. Without images or procedural films for review, the reported filter migration, tilt and perforation could not be confirmed and the exact cause could not be determined. Giving the limited information available at this time, clinical factor contributing to the migration could not be determined. 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 includes 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. The timing and mechanism of the filter tilt were not provided. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or 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 team, plaintiff underwent placement of a cordis opteasetm vena cava filter (referred to as "filter," "device" or "product" hereinafter) on or about (b)(6) 2015 at (b)(6) hospital and medical center in (b)(6). (b)(6), m. D. , was responsible for providing informed consent and placing the device. Upon information and belief, the device subsequently malfunctioned by, inter alia, migrating, tilting and perforating the vena cava, and by being thrombogenic. Plaintiff then underwent several failed medical procedures to retrieve the defective device, including one by (b)(6), m. D. On or about (b)(6) 2015.

 
Manufacturer Narrative

Imagery was received for analysis but the analysis report of the image is not yet available. Additional information is pending and will be submitted within 30 days upon receipt.

 
Manufacturer Narrative

Additional information was received and there was an attempt to remove the filter which failed. After the filter removal procedure, the patient was nausea, vomited small amount of emesis. Ice chips and zofran were given. The patient also complained of pain on the right neck; norco was given with relief. Urine was noted with blood, per patient, she is on her menstrual. Vital signs are stable and the patient will continue to be monitored. Imaging was performed by the physician in the heath facility and noncontrast ct abdo/pelvis shows a moderately tilted and partially disrupted (legs) filter in the infrarenal ivc.

 
Manufacturer Narrative

It was reported that a patient had an optease vena cava filter placed for bilateral pulmonary embolisms and deep vein thrombosis of the left common femoral vein, the superficial femoral vein and the left popliteal vein, subsequently malfunctioned by, inter alia, migrating, tilting and perforating the vena cava, and by being thrombogenic. A computerized tomography scan without contrast of the abdomen and pelvis was performed and showed a moderately tilted and partially disrupted (legs) filter in the infrarenal ivc, additional findings indicated that the filter was situated below the renal veins, the filter was fully deployed, with moderate tilt, no thrombus was visualized within the filter, an occluded infrarenal inferior vena cava and chronic occlusion of the right common and external iliac veins, chronic appearing occlusion of left common and external iliac veins and multiple transiliac pelvic venous collaterals. The patient underwent one failed medical procedure to retrieve the defective device approximately seven months after the initial implant. Two weeks later the filter was successfully removed. Ultrasound-guided right internal jugular, right femoral and left femoral access was gained for the removal procedure. In addition to removal of the filter, angiojet pharmacal mechanical thrombolysis and thrombectomy extending from the infrarenal ivc to bilateral common femoral veins was performed. Additional information indicted that after the filter removal procedure, the patient was nauseous and vomited small amount of emesis. Ice chips and zofran were given. The patient also complained of pain on the right neck; norco was given with relief. Urine was noted with blood, per patient, she is on her menstrual. Of note general anesthesia was used for the procedure. One angiographic image was received of an inferior vena cava filter. In this image, the filter appears to be in the upright position with the hook of the filter caudal. The integrity of the filter does not appear to be damaged in this image. The renal veins are not able to be visualized, therefore correct positioning of the filter is unable to be determined. An unknown catheter tip appears at top of image above filter. The purpose of the catheter is unknown. The filter is intended to be removed from femoral access only. Without having prior films/images to compare to, one is unable to determine migration of filter from original placement position. 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. Blood clots and thrombosis within the filter do not represent a device malfunction. Vena cava thrombus does not represent a device malfunction and could not be confirmed with the films made available for review, it is unclear of the etiology for the infra-renal ivc occlusion noted in the ct scan. With the procedural films made available for review, the reported filter tilt and perforation of the ivc could not be confirmed, additionally perforation and migration was not noted in the scan performed prior to removal of the device per the medical records. The timing and mechanism of the tilt has not been reported at this time. A clinical conclusion could not be determined as to the cause of the event. It is unknown if the tilt contributed to the reported perforation. The reported retrieval difficulty could not be confirmed and the exact cause could not be determined. The reported event notes implantation of the filter on or about (b)(6) 2015 with attempted retrieval in (b)(6) 2015. Retrieval of the optease vena cava filter is indicated up to 14 days post implantation. Usage of the product other than that indicated in the product's 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. Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter. The reported nausea with emesis and right neck pain is most likely associated with the side effects of the general anesthesia given during the removal procedure and the access gained in the right internal jugular vein and is a known potential short term side effect associated with administering anesthesia and insertion of a sheath or access catheter within the peripheral vasculature. Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

 
Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly. Additional information is pending and will be submitted within 30 days upon receipt.

 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
miami FL
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
miami FL
EI
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
MDR Report Key6511091
MDR Text Key73374606
Report Number1016427-2017-00269
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2016
Device MODEL Number466FXXXX
Device Catalogue Number466F220A
Device LOT Number15989727
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/04/2017
Event Location No Information
Date Manufacturer Received12/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/12/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/21/2017 Patient Sequence Number: 1
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