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

Model Number 7024

Device Problem Material Separation (1562)

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

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to volcano policy.A film of the implant was reviewed and it was discovered a kink was present before the retrieval process started.Femoral approach was used for retrieval.An 8fr inner sheath was used with a cook retrieval set.An ensnare snare was used after the retrieval tail couldn't be captured with the clover snare.No complications were reported.All anchors were present after being inspected after retrieval.Pre-decontamination: the delivery system was not returned for investigation.A visual inspection was performed on the returned filter.There was a fracture in the cw wireform, located approximately 1/3 up the length of the wire from the caudal end.The cw wireform also crossed under rather than over the ccw wireform, due to the fracture.The caudal end of the fracture site was encapsulated by the fep/ptfe tubing and the end of the tubing was tangled in the filter web.All 3 verticals and the horizontal thread of the web were intact.The retrieval tails were present and intact.All anchors were also present and no deformities were noted.The plasma balls, marker bands, and all crimps were also present and intact.Post-decontamination: a visual and microscopic inspection was performed.There was some discoloration on the cw wireform.The fep/ptfe tubing was also damaged at the fracture site location.This most likely occurred due to friction with the blunt end of the wire while the device was being retrieved from the body.We were unable to conclusively determine how the failure occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints were reported for this same failure mode within this lot.We will continue to monitor these types of complaints.

Event Description

It was reported the crux device was implanted 5 - 6 months ago.The filter broke during retrieval from the body.On inspection after retrieval all pieces were intact.There was no patient injury and no adverse events.All reasonably known patient information is included in this report.

• Brand Name: CRUX VENA CAVA FILTER SYSTEM, FEMORAL; CRUX VENA CAVA FILTER SYSTEM, JUGULAR
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: richard welch ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641301
• MDR Report Key: 5146031
• MDR Text Key: 28107536
• Report Number: 2939520-2015-00051
• 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
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2015
• Device Model Number: 7024
• Device Catalogue Number: 7024
• Device Lot Number: 0252 20030653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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 Age: 71 YR