MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA22-80/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Intimal Dissection (1333); Failure of Implant (1924); Ischemia (1942); Stenosis (2263); Vascular Dissection (3160)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
Patient initially implanted with a bifurcated stent and a suprarenal aortic extension.The afx devices were implanted to treat a dissecting aortic aneurysm.During the initial implant of the devices, the physician observed a type 3a endoleak and implanted a non-endologix gore stent to increase the overlap between the main body stent and the proximal extension.At the completion of the initial procedure the patient still had a residual type 3a endoleak remaining.The physician opted to conclude the procedure and monitor the patient.On (b)(6) 2017 the patient had limited blood flow to the legs and the physician elected to complete surgery to correct a retrograde dissection located at the right distal edge of the main body implant.The physician placed a coil in the right internal iliac artery along with a non-endologix gore stent to prevent limited blood flow from reoccurring.During the secondary intervention the reported residual type 3a endoleak was not observed and appeared to have resolved itself.The secondary procedure was completed and there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.The device was not returned therefore a sample evaluation was not completed.At the completion of the clinical assessment based on lack of information available, clinical was unable to confirm the reported intraoperative endoleak type iiia, right common iliac artery dissection at inferior stent margin of right iliac limb; secondary ev procedure-right iliac limb extension with non-endologix limb and coiling of right internal iliac artery.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 loss of seal at implant could not be determined due to lack of relevant medical information.Associated clinical harms for this event included; type iiia endoleak and aneurysm not excluded.The most likely cause of the procedure related right common iliac artery dissection (undetected at time of procedure) was the manipulations of multiple endovascular devices such as guidewires, sheaths and delivery systems (both endologix and non-endologix).The precise cause of the dissection cannot be determined due to a lack of medical records and imaging.Additionally the pre-existing condition of a dissection aortic aneurysm likely contributed to the event.Unable to determine off label or cautionary product use conditions.Associated clinical harms for this procedure related event included: ischemia (lower extremity), dissection (iliac and distal vessels), additional secondary endovascular procedure-limb extension (non-endologix) and coiled right internal iliac artery.The final patient disposition was reported as having no additional adverse events.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6599598
• Report Number: 2031527-2017-00271
• Device Sequence Number: 18853762
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)190823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2019
• Device Model Number: BA22-80/I16-40
• Device Lot Number: 1578836-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2017
• Supplement Date Received by Manufacturer: 04/30/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR