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

Catalog Number 466F210A

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2015

Event Type  Injury  

Event Description

The report received from the affiliate indicated that the product was inserted into the patient from femoral vein.When it came to the target lesion, the physician found that the blue and green marks of the product were reversed and he was concerned the product would not be recalled in the future.The product is still implanted in the patient.The specific status of the target lesion was unknown.The product was stored, handled, and prepped according to the ifu.There was no difficulty removing the product from the package.There was no unusual noted about the packaging or product prior to use.There was no kink noted on the device prior to use.The device did not pass through an acute bend.There was no difficulty advancing the device towards the target lesion.The product could not be returned at this time.The physician decided to remove the device 12 days after the first surgery.Additional details/clarification have been requested.

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.(b)(4).The initial report is (b)(6).The account information is currently unknown.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: the report received from the affiliate indicated that the product was inserted into the patient from femoral vein.When it came to the target lesion, the physician found that the blue and green marks of the product were reversed and he was concerned the product would not be able to be removed in the future.The product is still implanted in the patient.The specific status of the target lesion was unknown.The product was stored, handled, and prepped according to the ifu.There was no difficulty removing the product from the package.There was no unusual noted about the packaging or product prior to use.The physician decided to remove the device 12 days after implant.Multiple attempts have been made to gather additional information.However, no additional information regarding patient, lesion or procedural characteristics regarding this event has been provided.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The ifu instructs the following: ¿prior to releasing the optease retrievable filter from the sheath introducer ensure that: the intended filter location in the inferior vena cava is correct.Should the filter location be incorrect, reposition the sheath introducer; and the filter retrieval hook is orientated towards the caudal end of the vena cava.Should the filter orientation be incorrect, remove the sheath introducer (with filter inside) from the patient and discard the system.Recommence the procedure using a new sterile sheath introducer and storage tube with filter¿.The filter must be deployed in the patient with the hook oriented in the caudal position.In this orientation the fixation barbs are designed to prevent the filter from migrating towards the heart and it allows retrieval of the filter via the femoral vein.Retrieval of the optease filter is possible only from femoral vein approach.Implant of the optease filter with the hook oriented in the cranial direction can result in life threatening or serious injury including, but not limited to dissection, vessel perforation, migration of the filter with secondary damage to cardiac structures, ineffective pulmonary embolism prevention or death.The pictures received confirmed the filter was implanted upside down.However, without the storage tube available for analysis or films of the event, it is not possible to determine if the reported failure could be related to the manufacturing process.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 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: 4445489
• MDR Text Key: 5312695
• Report Number: 9616099-2015-00028
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2015

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 Expiration Date: 04/30/2017
• Device Catalogue Number: 466F210A
• Device Lot Number: 17011750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 01/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention