MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Difficult to Remove (1528)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

The product remains implanted and is thus not available for analysis.Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available. additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported by the physician to the sales rep that an optease filter was unable to be removed from the lesion and the filter remains in the patient.An optease was deployed as part of the treatment along with thrombus suction and tissue plasminogen activator (tpa) treatment.The patient received a blood anticoagulation examination prior to the filter being deployed.The filter had to be removed two weeks later, however it was unable to be removed.Anticoagulants were continued for a certain period of time.Stomach cancer as well as other types of cancer were confirmed.The patient required an operation therefore the medication was discontinued.It was confirmed that the patient did not have any deep vein thrombosis (dvt).After two weeks of not applying anticoagulants, the patient was said to have a portal vein occlusion, a vena lienalis occlusion and massive thrombus below both sides of the common femoral artery.The patient then started taking new oral anticoagulants (noac).The patient had another blood anticoagulation examination, however the result was not released.On (b)(6) 2016, the patient had pulmonary embolism.The patient was an (b)(6) male.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.The rate of stenosis was unknown.It was stated that the physician ¿spoke rapidly, some of the details can be incorrect.¿.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly: date received by mfr, type of reports, if follow-up, what type? and evaluation codes.It was reported by the physician that an optease filter was unable to be removed from the lesion and the filter remains in the patient.An optease was deployed as part of the treatment along with thrombus suction and tissue plasminogen activator (tpa) treatment.The patient received a blood anticoagulation examination prior to the filter being deployed.The filter had to be removed two weeks later, however it was unable to be removed.Anticoagulants were continued for a certain period of time.The patient history included stomach and other types of cancer were confirmed.The patient required an operation and therefore the medication was discontinued.It was confirmed that the patient did not have any deep vein thrombosis (dvt).After two weeks of not applying anticoagulants, the patient was said to have a portal vein occlusion, a vena lienalis occlusion and massive thrombus below both sides of the common femoral artery.The patient then started taking new oral anticoagulants (noac).The patient had another blood anticoagulation examination, however the result was not released.On january 2016, the patient had pulmonary embolism.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.The rate of stenosis was unknown.It was stated that the physician ¿spoke rapidly, some of the details can be incorrect.¿ the device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.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.Thrombosis does not represent a device malfunction.The reported retrieval difficult could not be confirmed as procedural films were not provided for review.The exact cause could not be determined.Given the information available for review, clinical factors contributing to the event could not be conclusively determined.With the information available and without the sterile lot number to conduct a dhr, there is no indication of a design or manufacturing related cause for this event; therefore, no corrective action will be taken at this time.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer (Section G): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6169429
• MDR Text Key: 62314562
• Report Number: 1016427-2016-00131
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/15/2016
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR