MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	IS20-25/C55 SA
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated with the afx abdominal aortic aneurysm stent.Approximately one (1) year post initial procedure, the patient presented with a type ib endoleak detected on ct.Re-intervention is planned but has not been scheduled.The patient's current status is unknown.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on (b)(6) 2018, (b)(6) 2018, (b)(6) 2018 and denied.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed; no contributing factors were identified.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).
Event or Problem Description
Additional information received confirming that the ct scan which diagnosed the reported type ib endoleak was completed on (b)(6) 2018.The physician elected to treat the patient by implanting an iliac limb ovation ix device on (b)(6) 2018.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7707372
• Report Number: 2031527-2018-00601
• Device Sequence Number: 1365936
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)180520
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2018
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1342611-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA SUPRARENAL-LOT 1484354-009; AFX2-BIFURCATED STENT GRAFT-LOT 1588487-014; OVATION IX-ILIAC LIMB-LOT FS030716-35; AFX-VELA SUPRARENAL-LOT 1484354-009; AFX2-BIFURCATED STENT GRAFT-LOT 1588487-014; OVATION IX-ILIAC LIMB-LOT FS030716-35
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR