MAUDE Adverse Event Report: ENDOLOGIX AFX; AFX INTRODUCER SYSTEM II

Model Number	S17-45
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/20/2018
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.
Event or Problem Description
During an initial procedure the marker band on the s17-45 sheath sheared off while removing the sheath.The issue was not found until after the vessel was closed at the end of the procedure.It was visualized under fluoroscopy but could not determine if it was in the vessel or in the subcutaneous layer.The physician decided to cut down in the patients right groin to explore.The marker band was found to partially be in and out of the vessel.The physician removed the marker band successfully.The patient is doing well post operatively.There has been no additional patient sequelae reported at this time.
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 and an inadequate 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.These types of events will be monitored and trended as part of the quality system.Patient code - remove 3165.Conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: AFX INTRODUCER SYSTEM II
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7853579
• Report Number: 2031527-2018-00707
• Device Sequence Number: 13844306
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)201215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 12/15/2020
• Device Model Number: S17-45
• Device Lot Number: 1768265009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 03/30/2019
• 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-1942978008; AFX2-LOT-1742162010; AFX-VELA SUPRARENAL-LOT-1942978008; AFX2-LOT-1742162010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR