MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE VENA CAVA FILTER

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 03/29/2017

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,the patient underwent placement of an optease vena cava filter but the filter reportedly subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the lvc filter, and recurrent dvt.  as a direct and proximate result of these malfunctions, the reportedly suffered life-threatening injuries and damages, and required extensive 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.Dvt does not represent a device malfunction.The reported dvt 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 in (b)(6), the patient underwent placement of an optease vena cava filter but the filter reportedly subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the lvc filter, and recurrent dvt.  as a direct and proximate result of these malfunctions, the reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The following additional information received per the patients' medical records indicates that the filter was placed due to morbid obesity with high risk for pulmonary embolism during bariatric surgery.The patient is reported to have tolerated the index procedure well without complications.The filter reportedly subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the lvc filter, and recurrent dvt.As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.The patient profile form accompanying the medical records states that the patient continues to experience anxiety related to the device.The filter remains implanted; thus, unavailable for analysis.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 occlusive thrombosis within the filter do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.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 VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6511759
• MDR Text Key: 73381954
• Report Number: 1016427-2017-00275
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/29/2017
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR