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

Model Number 466F220A

Device Problems Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Material Deformation (2976); Positioning Problem (3009); Unintended Movement (3026); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported that a patient was implanted with an optease vena cava filter.The patient tried contacting the doctors and the surgical facilities involved with the filter implantation to no avail and ultimately contacted cordis to inquire if the implanted device was part of a recall.The patient reports the filter expands from l1 through l3; it is tilted, and further reports undergoing two unsuccessful attempts to retrieve the filter.Procedural removal details were not provided.The patient also thinks that the device was put in backwards and is trying to find out if the device was under recall to get it taken out.According to the cordis urgent medical device (removal) customer letter dated (b)(6) 2013 sent for the optease catalog 466f220a, the optease lot the patient was implanted with (lot 15193960) was not on the product recall lot list.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As requested, the patient was contacted by phone by the clinician.Per telephone conversation the patient stated that the filter was placed for deep vein thrombosis (dvt) following an accident.The patient also stated that x-ray and computerized tomography (ct) imaging results completed about ten years and seven months after implantation, reported that the device was implanted upside down.Additionally, the patient reports undergoing two unsuccessful attempts to remove the filter, made by the same physician, sometime after implantation.The first attempt was made through the neck and the filter could not be removed because it was embedded, according to the patient.The second attempt access was made from both the groin and the neck.The patient further asserts there was a third attempted removal; however, was unsure of the access site, and that the physician had indicated at the time that the filter could not be removed because it might damage the vein.The patient additionally reports tilting along with slight filter migration.Medical records were requested for review but have not yet been provided.

Event Description

Additional information was received from the patient post phone call.The information received comprises of a copy of a voluntary med-watch (mw5106714) submitted by the patient to fda on (b)(6) 2022 for catalog 466f220a lot 15193960.Additionally, two photos of the operative report were enclosed.Per the operative report, the patient was reported to have a preoperative diagnosis of deep vein thrombosis (dvt) on prophylaxis.Under moderate sedation, using intravascular ultrasound (ivus) guidance for guidewire device placement and inferior vena cava (ivc) mining, the patient underwent deployment of the optease inferior vena cava filter.Local anesthesia was delivered to the patient¿s left groin, and a needle was used to locate the left common femoral vein.On a single puncture attempt, a guidewire was placed in the vein and the entrance site was enlarged using a sheath introducer and dilator; both of which were removed, and an ivus catheter was advanced over the guidewire.The ivc from the right atrial junction to the external iliac vein was insonated.The renal vein ostia were identified.The infrarenal ivc measured less than 20mm and the distance to the renal veins was determined.The catheters were removed, and the sheath advanced to the measured distance.The optease filter was then deployed.The ivus was exchanged, and excellent infrarenal position was confirmed.The patient tolerated the procedure well.

Manufacturer Narrative

A patient called medical affairs to inquire about the optease filter that they were implanted with, the patient wanted to know if it was part of a recall.The patient indicated that the filter expands from l1 through l3, is tilted, and underwent two unsuccessful attempts to retrieve the filter.The patient reported that they had tried contacting the doctors and the surgical facilities involved with the filter implant, but were not able to get any information, and ultimately contacted cordis to inquire if the implanted device was part of a recall.The patient also thinks that the device was put in backwards and is trying to find out if the device was under recall to get it taken out.Per telephone conversation the patient stated that the filter was placed for deep vein thrombosis (dvt) following an accident.The patient also stated that x-ray and computerized tomography (ct) imaging results completed about ten years and seven months post implant, reported that the device was implanted upside down.Additionally, the patient reports undergoing two unsuccessful attempts to remove the filter, made by the same physician, sometime after implantation.The first attempt was made through the neck and the filter could not be removed because it was embedded, according to the patient.The second attempt access was made from both the groin and the neck.The patient further asserts there was a third attempted removal; however, was unsure of the access site, and that the physician had indicated at the time that the filter could not be removed because it might damage the vein.The patient additionally reports tilting along with slight filter migration.Two photos of the operative report were received.Per the operative report, the patient was reported to have a preoperative diagnosis of deep vein thrombosis (dvt) on prophylaxis.Under moderate sedation, using intravascular ultrasound (ivus) guidance for guidewire device placement and inferior vena cava (ivc) mining, the patient underwent deployment of the optease inferior vena cava filter.Local anesthesia was delivered to the patient¿s left groin, and a needle was used to locate the left common femoral vein.On a single puncture attempt, a guidewire was placed in the vein and the entrance site was enlarged using a sheath introducer and dilator; both of which were removed, and an ivus catheter was advanced over the guidewire.The ivc from the right atrial junction to the external iliac vein was insolated.The renal vein ostia were identified.The infrarenal ivc measured less than 20mm and the distance to the renal veins was determined.The catheters were removed, and the sheath advanced to the measured distance.The optease filter was then deployed.The ivus was exchanged, and excellent infrarenal position was confirmed.The patient tolerated the procedure well.The product remains implant and therefore not available 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 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 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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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 explant problems after as short a period as 12 days.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the 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.The optease filter is intended for both femoral and jugular/antecubital approach.The filter cartridge is labeled to indicate the direction for filter placement.According to the ifu, which is not intended as a mitigation for risk, the obturator serves to advance the filter from the storage tube into the sheath introducer and to advance the filter through the sheath introducer to the implantation site.The constrained filter is supplied in a plastic storage tube, which is to be loaded as a system into the sheath introducer hemostasis valve.The storage tube is printed with colored arrows and text (femoral: green; jugular/antecubital: blue) to indicate the correct orientation.The arrow of the desired access site will point into the sheath introducer hemostasis valve.With the limited information provided and no images available for review the reported events could not be confirmed or further clarified.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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 13385370
• MDR Text Key: 284687993
• Report Number: 9616099-2022-05319
• 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,Followup,Followup,Followup
• Report Date: 03/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15193960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2010
• 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
• Treatment: BARD KIT INTRODUCER SHEATH AND DILATOR; UNK 18G NEEDLE; VOLCANO PV . 035 DIGITAL IVUS CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Sex: Female