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

Model Number	IS20-25/C55 SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	11/16/2016
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
On (b)(6) 2015, the patient was initially implanted with an afx bifurcated stent graft.Approximately 1.5 years later there was a ct scan performed in (b)(6) 2016 showing an ectatic iliac that grew to a treatable size (4cm); a bellbottom limb was placed originally and then became undersized to the iliac.On (b)(6) 2017, a secondary procedure) was performed ;during the intervention, an additional limb stent graft was implanted.The procedure was done by placing a 20-13-88 limb extension and the op note says that a completion angiogram was performed showing no type 1 or type 3 endoleak.No patient sequelea has been reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events: a secondary endovascular procedure and a left iliac sac growth additional findings include a type ib endoleak in the lcia.The most likely cause of the distal loss of seal could not be determined due to the lack of medical information surrounding the implant procedure.Procedure related harms and final patient disposition could not be ascertained.To date there has been no reports of negative patient sequalae.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7470206
• Report Number: 2031527-2018-00346
• Device Sequence Number: 1051987
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)180117
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2016

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: 11/18/2017
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1253181013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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: LIMB STENT GRAFTVELA INFRARENAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR