MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number A28-28/C95V

Device Problems Collapse (1099); Folded (2630)

Patient Problems Failure of Implant (1924); Ischemia (1942); Occlusion (1984); Thrombosis (2100); Claudication (2550); Blood Loss (2597)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation.Devices have been discarded at the hospital.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with a bifurcated stent and an infrarenal aortic extension.On (b)(6) 2017 the patient came in emergently with a cold leg.Computed tomography (ct) showed the patient had an occlusion from the proximal extension which was reported to have collapsed.The physician elected to explant the devices and complete an open repair.The devices were discarded at the hospital.The patient is reported to be in good condition and there have been no additional adverse events reported.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were not enough evidence to support the following case event.It was confirmed that patient had bilateral leg pain due to a collapsed, occluded proximal graft (ir cuff and mainbody).The report of cold legs were refuted, rather patient had a bilateral buttock claudication instead.Physician elected to do a surgical conversion (open repair), and device was discarded at the hospital.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The occlusion of the graft was most likely due to the proximal cuff collapse.The most likely cause of the buckled proximal cuff (collapse) could not be determined due to a lack of relevant imaging.Associated clinical harms for this event included: pain, ischemia, occlusion, surgical conversion, and abnormal blood loss.Additionally, the patient was readmitted twice during the thirty days following the conversion for low hemoglobin counts, and was treated medically (procedure related).The final patient disposition was discharged home with home health care and to be in good condition with no additional adverse events reported.A review of manufacturing lot confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Type of Device: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7124558
• MDR Text Key: 95176162
• Report Number: 2031527-2017-00677
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013521
• UDI-Public: (01)00818009013521(17)191020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2019
• Device Model Number: A28-28/C95V
• Device Lot Number: 1604467-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR