MAUDE Adverse Event Report: VOLCANO CORPORATION CRUX VENA CAVA FILTER SYSTEM, JUGULAR; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 7025

Device Problems Difficult to Remove (1528); Device Issue (2379); Material Distortion (2977)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to philips volcano policy.An image taken in (b)(6) 2015 between implant and removal indicated the filter was sitting askew.There was nothing reported at the time of delivery on difficulty deploying or deployment in a way that made clot trapping ineffective.Implant notations stated "successful filter deployment" and no issues were noted.The manufacturer was unable to obtain any product information for the implanted device.Visual and microscopic inspections were performed on the returned device.The delivery system was not returned.It was observed that the wireform was deformed.The cranial loop of the wireform was larger than the caudal loop.However, when the filter webbing was untangled from the r2 anchor, the wireform became less deformed.During visual inspection, we were able to verify the reported complaint of the cranial loop being larger than the caudal loop of the wireform.In vivo images provided by the facility reveal that the filter was misshapen prior to retrieval.Although a kink appears to be present in one of the images provided, no kink was observed during analysis of the returned device.The images provided by the facility suggest that this crux filter kinked just above the r2 tissue anchor sometime during the ~4.5 months following implantation.The non-oval, irregular shape of the caudal loop prior to retrieval indicates that the thrombus trapping properties of this filter were likely compromised; e.G., without full coverage of the inferior vena cava (ivc), thromboemboli can evade capture by passing between the margin of the caudal loop and the caval wall.Patient injury was not reported in this case; however, there is a potential risk for injury if this event were to recur.All parts of the crux filter involved in this case appeared to be accounted for - both according to the physician's assessment at the time of retrieval, and the images/photographs provided for review.It is possible the webbing became tangled around the r2 anchor during retrieval of the device.This may have caused the disparity in filter loop size.However, we were unable to conclusively determine how or when the device became deformed while inside the patient.The instructions for use (ifu) warns that the movement, migration and/or tilt are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal filter migration.Migration may be caused by placement in ivcs with diameters exceeding the dimensions specified in the ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.To date, no other complaints were reported for this same failure mode within this lot.We will continue to monitor these types of review complaints.

Event Description

It was reported the patient had surgery and developed a deep vein thrombosis (dvt).An interventional radiologist (ir) implanted a crux ivc filter on (b)(6) 2015.During the follow-up extraction procedure, the surgeon had difficulty removing the filter.The filter appeared unequally distributed in the ivc with the cranial loop much larger than the caudal loop, and apparently had been that way for some time.The manufacturer's representative (rep) was asked to help after the procedure had been going on for about an hour without success.Femoral access was used to enter the ivc with a cook retrieval set.According to the user, the filter was embedded in the wall and the physician could not get the snare around it.Forceps were used through the sheath to "catch" the distal retrieval tail.After repeatedly doing this, and not losing the tail once inside the 6 french, the surgeon advanced the 10 french sheat with difficulty multiple times.Both the six (6) and 10 french sheaths were torn apart on the distal end and almost didn't advance enough to allow filter removal.The surgeon examined the filter and indicated it appeared intact.Patient's pre-procedural diagnosis was noted as "sub massive pe [pulmonary embolism]." patient is 6'3".Attempts to obtain patient id and age have been unsuccessful.Attempts to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.

• Brand Name: CRUX VENA CAVA FILTER SYSTEM, JUGULAR
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr ste 500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 5734270
• MDR Text Key: 47702662
• Report Number: 2939520-2016-00033
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2016

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 Expiration Date: 06/30/2016
• Device Model Number: 7025
• Device Catalogue Number: 400-0200.235
• Device Lot Number: 0253 20058008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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): Required Intervention
• Patient Weight: 76