MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU; THROMBECTOMY SYSTEMS (DTK)

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product coming back but not yet received: the product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.

Event Description

During the deployment of an optease retrievable filter to the vena cava, it was reported that the filter does not fully expand after deployment at the target site.Much of the hook end expanded by about 20% after the release of the filter.The procedure was completed by using another product.There was no patient injury due to the device malfunction.The product will be returned for analysis.Upon opening the device package, everything was normal.It is unknown if the thermal indicator was activated.It is unknown if it was verified under fluoroscopy that the filter or part of the filter was not in a side vessel.The vessel characteristics are unknown.It is unknown if there were any acute bends, tortuosity, calcification, thrombosis or stenosis.It is unknown if there was wall apposition deemed adequate to prevent migration.When the operation was completed, the surgeon flushing the filter, found it was expand in patient vitro after he turned the filter.The indication for filter insertion is unknown.Pre/post imaging was completed.Pictures have been provided.

Manufacturer Narrative

Complaint conclusion: during the deployment of an optease retrievable filter to the vena cava, it was reported that the filter did not fully expand after deployment at the target site.¿much of the hook end expanded by about 20%¿ after the release of the filter.The procedure was completed by using another product and no patient injury was reported.The indication for filter insertion is unknown.The vessel characteristics are unknown.It is unknown if there were any acute bends, tortuosity, calcification, thrombosis or stenosis.Upon opening the device package, no abnormalities were noted.It is unknown if the thermal indicator was activated.It is unknown if it was verified under fluoroscopy whether or not the filter or partly in or within a side vessel.It is unknown if there was wall apposition deemed adequate to prevent migration.When the operation was completed, the surgeon flushing the filter, found ¿it was expand in patient vitro after he turned the filter.¿ pre/post imaging was completed.Images provided were reviewed and show what appears to incomplete expansion of the filter.The product was returned for analysis.A non-sterile unit of optease retrievable filter was received inside of a plastic bag.An obturator, a csi cannula, a storage tube, a vessel dilator and a filter were received.The storage tube was received inserted on the obturator which was received inserted in csi cannula.The filter was received fully expanded.No damages were observed on vessel dilator.The filter was inspected under vision system y no damages were observed on filter barbs.Review of lot 17189238 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported ¿filter/ incomplete expansion¿ was confirmed through images provided by the customer which noted a ivc filter that was not completely expanded.However, upon return of the device, the filter was received fully expanded with no damage noted.The exact cause of the difficulty experienced by the customer could not be determined.Clinical factors that may have contributed to the incomplete expansion of the filter (such as stenosis) are unknown.The instructions for use (ifu) note that the constrained filter is flexible and achieves its unconstrained diameter upon deployment in the inferior vena cava.Upon deployment, the filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability.Neither the dhr review nor the product analysis suggests that the difficulty experienced by the customer is related to the design or manufacturing process; therefore, no corrective action will be taken at this time.

Manufacturer Narrative

A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

• Brand Name: OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU
• 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: 5567216
• MDR Text Key: 42385059
• Report Number: 9616099-2016-00180
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17189238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2016
• Date Device Manufactured: 02/26/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 70