MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PERMANENT VENA CAVA FILTER 55CM; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306AU

Device Problems Positioning Failure (1158); Kinked (1339); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device remains implanted in the patient; therefore, the device is not available to be returned for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the trapease filter did not deploy because it was released in the ovarian vein.The patient had copd and could not lie flat.Access was femoral.The physician believes the sheath was kinked which did not allow the device to deploy properly.It left the sheath but was in a location that did not accommodate the expansion of the filter.The filter remained in place and another trapease was implanted without incident.No patient injury.No issues with the packaging or during the prep.It appears to have been operator error.

Manufacturer Narrative

Complaint conclusion: as reported, the trapease filter did not deploy because it was released in the ovarian vein.The patient had copd and could not lie flat.Access was femoral.The physician believes the sheath was kinked which did not allow the device to deploy properly.It left the sheath but was in a location that did not accommodate the expansion of the filter.The filter remained in place and another trapease was implanted without incident.No patient injury.No issues with the packaging or during the prep.It was reported that ¿it appears to have been operator error.¿ the device was not returned for analysis.Review of lot 17215220 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Without return of the device for analysis or procedural films for review, the reported ¿inaccurate placement¿ of the filter could not be confirmed and the root cause could not be conclusively determined.The trapease® filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava.The instruction for use instruct to ¿position the sheath introducer radiopaque tip and the marker bands of the angiographic vessel dilator in the inferior vena cava below the renal veins in preparation for an angiographic overview of the ivc.Determine the diameter of the inferior vena cava at the intended implantation site below the lowest renal vein by injecting contrast medium through the angiographic vessel dilator and using its marker bands as a reference.¿ based on the information available for review, procedural factors may have contributed to the difficulty experienced by the customer.Neither the dhr nor the event description suggests a design or manufacturing related cause for the event; therefore, no corrective action will be taken at this time.

• Brand Name: TRAPEASE PERMANENT VENA CAVA FILTER 55CM
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• 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: 5402531
• MDR Text Key: 37305815
• Report Number: 9616099-2016-00049
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17215220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability