MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; VENA CAVA FILTER

Model Number N/A

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)

Patient Problems Embolus (1830); Occlusion (1984)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.As reported in the legal brief (b)(6), an unspecified period of time after an optease vena cava filter was implanted, the filter reportedly embedded itself in the ivc wall causing injury and damages including but not limited to blood clots, clotting and occlusion of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment. the product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number. the optease 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.Clots, blood clots and occlusion do not represent a device malfunction.The reported events could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.

Event Description

As reported in the legal brief (b)(6), an unspecified period of time after an optease vena cava filter was implanted, the filter reportedly embedded itself in the ivc wall causing injury and damages including but not limited to blood clots, clotting and occlusion of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates the filter was placed due to deep vein thrombosis (dvt) which involving the popliteal and the superficial femoral vein on the left side.Approximately six weeks post implantation, an unsuccessful attempt was made to retrieve the filter.Medical records indicate that the retrieval hook was engaged but the barbs could not be freed from the vessel wall.The patient is reported to continue to experience swelling and psoriasis of the left leg, numbness in the right pelvic area and right leg and anxiety related to the device.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent implantation of an optease inferior vena cava (ivc) filter.Per the patient profile form (ppf), the filter was placed due to deep vein thrombosis (dvt) which involving the popliteal and the superficial femoral vein on the left side.Subsequently, the filter reportedly embedded itself in the ivc wall causing injury and damages including but not limited to blood clots, clotting and occlusion of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.Approximately six weeks post implantation, an unsuccessful attempt was made to retrieve the filter.Medical records indicate that the retrieval hook was engaged but the barbs could not be freed from the vessel wall.The patient is reported to continue to experience swelling and psoriasis of the left leg, numbness in the right pelvic area and right leg and anxiety related to the device.The filter remains implanted; thus, unavailable for analysis.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 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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, 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.Blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Swelling of the legs, numbness and psoriasis do not represent device malfunctions and are most probably related to the underlying coagulopathy that was part of the indication for filter placement.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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: VENA CAVA FILTER
• 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 60th ave; miami lakes, FL 33014
• MDR Report Key: 6614680
• MDR Text Key: 76754992
• Report Number: 1016427-2017-00342
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15104657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/17/2017
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 35 YR