MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE VENA CAVA FILTER; THROMBECTOMY SYSTEMS (DTK)

Catalog Number 466F220A

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Embolism (1829); No Consequences Or Impact To Patient (2199)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.

Event Description

As per medical affairs, a patient called reporting that on (b)(6) 2011 he had an optease filter placed in unknown vessel due to blood clots in his left leg at tulane hospital after a 10 day admission.The patient reported that the optease filter was placed upside down and has the mri films "that show the hook is longer than the other side".Per the patient "that's all i can say at this point-any other issues i have are irrelevant", no other information obtained at this time.

Manufacturer Narrative

Additional information received by the patient, indicated that approximately 8 months ago he felt ¿a small clot in his heart.¿ he was seen by his vascular surgeon in whom it was confirmed that the filter was placed upside down in 2011.Per the patient, removing the filter is not an option.The patient claims he has medical records of his procedure, however, refuses to share them.The patient abruptly disconnected the phone.Complaint conclusion: as per medical affairs, a patient called reporting that in (b)(6) 2011, an optease ivc filter was placed in an unknown vessel due to blood clots in his left leg following a 10 day hospital admission.The patient reported that the optease filter was placed upside down and has the mri films ¿that show the hook is longer than the other side".Per the patient "that's all i can say at this point-any other issues i have are irrelevant", no other information could be obtained at the time.Upon additional follow up, the patient reported that approximately 8 months ago he ¿felt a small clot in his heart.¿ he was seen by his vascular surgeon who confirmed that the filter was placed upside down in 2011.Per the patient, removing the filter is not an option.The patient states he has medical records of his procedure; however, refuses to share them.The call was abruptly disconnected with no additional information provided.The device was not returned as it remained implanted in the patient.A device history record review could not be conducted as a sterile lot number was not provided.Inferior vena cava filters are used to prevent pe in patients with contraindications to or complications of, anticoagulation therapy and patients with extensive free-floating thrombi or residual thrombi following massive pe.Current evidence indicates that ivc filters are largely effective; breakthrough embolus occurs in only 0% to 6.2% of cases.Recurrent embolus/pulmonary embolus may occur with long-term use and is noted in the instructions for use.Without return of the device or procedural films for review the reported ¿filter - inaccurate placement-upside down¿ could not be confirmed and the exact cause could not be determined.Based on the limited information available for review, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.The ifu lists incorrect filter positioning and incorrect orientation of the filter as possible placement procedure complications.The ifu instructs that according to the selected venous access site, determine which end of the storage tube (containing the filter) is to be placed into the valve of the sheath introducer.This is indicated by the printed colored arrows and text (femoral: green; jugular/antecubital: blue) on the storage tube.The arrow of the desired access site will point into the sheath introducer hemostasis valve.Place the appropriate end of the storage tube (containing the optease® filter), as far as possible into the sheath introducer hemostasis valve.Incorrect filter deployment orientation has been previously investigated and corrective and preventive actions have been implemented.No other actions will be taken at this time.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5083733
• MDR Text Key: 26115712
• Report Number: 9616099-2015-00436
• 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: consumer
• Reporter Occupation: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 118