MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE VENA CAVA FILTER

Model Number N/A

Device Problem Occlusion Within Device (1423)

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) vs.Cordis, an unspecified period of time after an optease vena cava filter was implanted, the filter reportedly malfunctioned bty  embedded itself to 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) vs.Cordis, an unspecified period of time after an optease vena cava filter was implanted, the filter reportedly malfunctioned bty embedded itself to 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

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent implant of an optease inferior vena cava (ivc) filter.Per the patient profile form (ppf), the filter was placed for morbid obesity with pending surgery.The filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting, occlusion, and perforation 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 patient is reported to have experienced tilting of the device, pain, swelling and numbness in the left leg, chest pain, abdominal pain, and continues to experience anxiety that requires medical treatment 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.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.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.

Manufacturer Narrative

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

Manufacturer Narrative

As reported, the patient had an optease inferior vena cava(ivc) filter implanted.Per the medical records, the filter was placed for left leg massive iliofemoral venous thrombosis.The filter was placed in the normal location between l1 and l2.The patient then received five milligram bolus of tpa via the popliteal vein as well as underwent mechanical thrombolysis.The patient is reported to have tolerated the index procedure well.The filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting, occlusion of the inferior vena cava (ivc).Approximately four years post implantation, the patient underwent an unsuccessful attempt to retrieve the filter.During the removal attempt, the majority of the filter was sheathed.However, the superior portion of the filter was unable to be captured, likely secondary to adherence to the ivc wall.Despite numerous attempts the removal was not achieved.Repeat cavogram demonstrated no evidence for extravasation with intact filter.Inferior venacavogram and pelvic venogram demonstrated no thrombus within the filter with a widely patent left external iliac stent and draining common iliac stent.The patient tolerated the procedure well and left the angiography suite in stable condition.Per the patient profile from (ppf), the patient reports filter embedded in the wall of ivc, device unable to be retrieved, and an unsuccessful percutaneous removal procedure was performed.The patient also reports stress, anxiety and having a poking feeling on the right side stomach below the rib cage.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.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 and vasculature do not represent a device malfunction.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 VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• MDR Report Key: 6614868
• MDR Text Key: 76773383
• Report Number: 1016427-2017-00344
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2017
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR