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

Model Number 7024

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 03/20/2014

Event Type  Injury  

Event Description

Crux vcf was initially implanted on (b)(6) 2014 and the occlusion was confirmed on (b)(6) 2014.Patient history included trauma with intracranial bleeding.The patient was unable to be anticoagulated due to the intracranial bleed.At the time of the crux vcf insertion, the patient had a right common iliac dvt as well as bilateral soliel vein dvt.The physician stated that the ivc diameter was about 17mm.The crux vcf was deployed via the left femoral vein approach.On (b)(6) 2014, the patient developed dvt in the left iliac vein which continued into the ivc and crux vcf all the way up to the level of the renal veins.This dvt was diagnosed via venous duplex ultrasound.The patient then had a venogram completed to assess the extent of the thrombosis.The physician stated that the ivc and crux vcf showed no flow and was occluded.Volcano clinical rep reported that the filter was removed and another company filter was implanted.The date of crux retrieval is currently unknown.

Manufacturer Narrative

(b)(4).This device was not returned to the manufacturer and serial and lot # of the filter system was not available to be reported by the clinical staff.Without this information, manufacturing documentation for this device was not able to be reviewed to confirm the device met all quality and manufacturing release criteria.In addition, without this information we are unable to confirm that to date, if any other complaints have been reported for this failure mode within this device's lot.Since the physician reported the vessel to be occluded and that intervention was required (filter retrieval) this report is being submitted due to an abundance of caution.A supplemental report will be submitted when the manufacturer's scientific affairs department completes the clinical assessment for this case.

• Brand Name: CRUX VENA CAVA FILTER SYSTEM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA
• Manufacturer Contact: denise stearns ; 3721 valley centre dr.; suite 500; rancho cordova, CA 95670 ; 8587204178
• MDR Report Key: 3778218
• MDR Text Key: 4434261
• Report Number: 2939520-2014-00029
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 7024
• Device Catalogue Number: 7024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2014
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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