MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT

Model Number BEA22-80/I16-40

Device Problems Collapse (1099); Difficult or Delayed Positioning (1157); Use of Device Problem (1670)

Patient Problems Failure of Implant (1924); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

To date the incident devices have not been received for evaluation.If the devices are received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

A patient with a pre-existing aortic dissection type b was implanted with a bifurcated stent graft.During the initial implant procedure, the physician had difficulty deploying the device and a delivery system wire broke off inside the patient.When attempting to remove a wire through the bifurcated stent graft delivery system the contralateral limb of the bifurcated stent collapsed.The physician had to use a balloon catheter to open up the limb and placed a limb extension to keep the contralateral side of the implant lumen open.The physician attempted to retrieve the wire and was unsuccessful, an additional limb extension was placed to secure the wire remaining in the patient.It was also reported the patient had low hematocrit, a orotracheal tube post procedure, and a total blood loss of 1200cc's were a 1000cc's were due to the prolonged procedure.The final patent status has not been reported to endologix.To date there have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were not enough information to support the following case event.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the damaged/broken component, difficulty to deploy, stent buckling and inability to remove the wire could not be determined due to a lack of any medical records and imaging.Procedure related harms and the final patient disposition could not be determined.Reported the patient was doing well; there have been no further reports of negative patient sequelae.The delivery system was returned and the following components were evaluated by direct observation of physical device: one s17-45 introducer systems and one afx bea22-80/i16-40.The evaluation result for the s17-45 and the afx bea22-80/i16-40 did not support the reported the reported event of difficult deploy, damaged broken component.No physical damage or defects were observed on the returned device.A review of the manufacturing lot confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6846866
• MDR Text Key: 85079377
• Report Number: 2031527-2017-00451
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)180522
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

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: 05/22/2018
• Device Model Number: BEA22-80/I16-40
• Device Lot Number: 1689609-008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR