MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I13-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	03/16/2017
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 implanted with an afx2 bifurcated stent graft, vela suprarenal, and two (2) vela infrarenals on (b)(6) 2017.After the index procedure was completed the same day, the patient's blood pressure dropped and the implanting physician concluded that the patient had a rupture in the iliac.This physician then re-accessed the patient's groin and implanted two (2) ovation limb stent grafts and three (3) extenders to stop the bleeding.
Additional Manufacturer Narrative
An 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 23 mar 2018 and 30 mar 2018 and no response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.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.Correction: date of report.Additional information: relevant tests/laboratory data, other relevant history, device manufacture date.Add method code 4119.Add conclusion code 4315.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445918
• Report Number: 2031527-2018-00186
• Device Sequence Number: 13895479
• Product Code: MIH
• UDI-Device Identifier: 00818009014788
• UDI-Public: (01)00818009014788(17)170429
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

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: Physician
• Device Expiration Date: 04/29/2017
• Device Model Number: BEA25-80/I13-40
• Device Lot Number: 1472921-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 07/30/2018
• 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 INFRARENAL - LOT 1252186-020; AFX-VELA INFRARENAL - LOT 1624768-019; AFX-VELA SUPRARENAL - LOT 1252032-010; AFX-VELA INFRARENAL - LOT 1252186-020; AFX-VELA INFRARENAL - LOT 1624768-019; AFX-VELA SUPRARENAL - LOT 1252032-010
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 85 YR