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

Model Number N/A

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Pseudoaneurysm (2605)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

As reported in a legal brief, in an unspecified period after an optease filter was placed, the filter subsequently malfunctioned and later fractured causing injury and damages to the patient, including but not limited to, two failed removal surgeries, pseudoaneurysm of the ivc wall, vein stenosis, and subsequent complex filter retrieval surgical procedure, requiring an ivc stent graft placement.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.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.Vessel injury is a well-known potential complication for all ivc filter implants and is listed in the instructions for use (ifu) as such.Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.The dates of implantation and attempted retrieval are unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 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.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) vs.Cordis, an unspecified period after an optease filter was placed, the filter subsequently malfunctioned and later fractured, causing injury and damages to the patient, including, but not limited to, two failed removal surgeries, pseudoaneurysm of the ivc wall, vein stenosis, and subsequent complex filter retrieval surgical procedure, requiring an ivc stent graft placement.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, an unspecified period after an optease inferior vena cava (ivc) filter was placed.Per the patient profile form (ppf), the filter was placed due to a history of lower extremity varicosities, pulmonary nodules with negative ppd, left ulnar artery aneurysm, ischemic thrombosis 3rd left digit, and almost occlusive popliteal dvt.The patient is reported to have tolerated the index procedure well, there were no apparent complications.The filter subsequently malfunctioned and later fractured, causing injury and damages to the patient, including, but not limited to, two failed removal surgeries, pseudoaneurysm of the ivc wall, vein stenosis, and subsequent complex filter retrieval surgical procedure, requiring an ivc stent graft placement.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.The patient underwent two failed attempts to retrieve the filter.The first attempt was 10 weeks post implant.The filter was noted to deflect slightly inferiorly but could not be freed.The second attempt was approximately nine years post implant.The filter was noted to have two pre-existing strut fractures at this time.The patient underwent a third attempt approximately nine years and four months post implant.This was a successful complex retrieval of the filter and all fractured struts requiring stenting.The patient has experienced anxiety related to the device and the complex retrieval that required stenting.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.Venous stenosis is a known adverse event associated with device implantation within the vasculature.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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.Pseudoaneurysm is a known adverse even associated with all vascular implantation/intervention procedures.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 comorbidities, 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.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of this report.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6375180
• MDR Text Key: 68967009
• Report Number: 1016427-2017-00203
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2009
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: R0306635
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/07/2017
• Date Manufacturer Received: 01/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 53 YR