MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX

Model Number BA28-100/I16-40

Device Problems Hole In Material (1293); Leak/Splash (1354); Premature Activation (1484); Retraction Problem (1536); Failure to Advance (2524)

Patient Problems Congestive Heart Failure (1783); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Rupture (2208); Respiratory Failure (2484); No Code Available (3191)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation.If additional info pertinent to the incident is obtained, a follow-up report will be submitted.Additional device info: model and lot# of other involved device: model#: ba25-120/i20-40; lot#1283306-008; dom: (b)(6) 2014; expiration date: 12/12/2017; (b)(4).

Event Description

It was reported that the patient had a procedure on (b)(6) 2012 with a bifurcated, suprarenal and limb extension.On (b)(6) 2015, the pt was admitted to the hospital with a rupture.Ct scan revealed an endoleak type iiib and the physician elected to reline the graft.While advancing the delivery system inside the sheath from the common iliac into the aorta, the sheath retracted inadvertently exposing the device completely and the device could not be advanced.After pushing, the device prematurely deployed in the common iliac.At that point, the decision was made to explant.No patient injury reported.

Manufacturer Narrative

Based upon the clinical assessment, the reported type iiib endoleak and rupture was confirmed.A manufacturing record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.Based upon the investigation, a root cause was not definitely identified, therefore, identification of a design or manufacturing issue is inconclusive.The clinical review identified the following factors that may have contributed to the patient outcome: calcifications near the type iiib endoleak; photos sent of the explant showed a stent strut protruding prominently through the fabric of the stent.The cause could not be determined from review of the picture, but the strut looks as if it has been bent out of proper position from an unknown cause.In the picture there also what appears to be a possible small hole at the suture line.H10: an additional bifurcated was not used ba25-120/i20-40 lot:1283306-008.

Event Description

(b)(6) 2015.

• Brand Name: AFX
• Manufacturer (Section D): ENDOLOGIX, INC.; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5235465
• MDR Text Key: 31618199
• Report Number: 2031527-2015-00452
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

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 Expiration Date: 09/30/2015
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1047124-014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• 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 Age: 68 YR