MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX SYSTEM; SUPRARENAL PROXIMAL EXTENSION STENT GRAFT (SCS)

Model Number A28-28/C95-O20V

Device Problems Sticking (1597); Unintended Movement (3026)

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

Event Date 04/16/2014

Event Type  malfunction  

Event Description

It was reported that during implantation of a bifurcated device, and suprarenal aortic extension, the cuff jumped up a few millimeters.Reportedly, the cuff jumped up a few millimeters upon final unsheathing, and partially covered the left renal.The physician attempted to pull the cuff down with coda balloon, but could not get the cuff to move down any further.The renals are filling and the patient tolerated the procedure well, and will receive a 30-day follow up.

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional information becomes available.Device remains implanted in patientf.

Manufacturer Narrative

The device remains implanted in the patient hence, device evaluation could not be performed.Based upon the investigation findings, the reported event is inconclusive.There were suboptimal medical records and imaging studies provided for this assessment.There was no radiological evidence to substantiate the reported "jump" during deployment other than the misaligned cuff on the final angiography image.There was no evidence of renal failure at discharge, there was no apparent injury to the patient.A manufacturing record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.The lot usage history showed that no other units from the same lot have been involved in any similar event.The product labeling was reviewed, and confirmed that the reported event is adequately captured in the existing labeling.Based upon the investigation findings, a root cause could not be conclusively determined; however, handling of the device might have been a factor.

• Brand Name: AFX SYSTEM
• Type of Device: SUPRARENAL PROXIMAL EXTENSION STENT GRAFT (SCS)
• Manufacturer (Section D): ENDOLOGIX, INC.; 11 studebaker; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 11 studebaker; irvine CA 92618
• Manufacturer Contact: gail hapner ; 11 studebaker; irvine, CA 92618 ; 9495984611
• MDR Report Key: 3806538
• MDR Text Key: 16085325
• Report Number: 2031527-2014-00129
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• 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,Followup
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/30/2015
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1203996-023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 05/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2014
• 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: 72 YR