MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA INFRARENAL CUFF

Model Number	A34-34/C80 V
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Stretched (1601)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In addition to the confirmed type 3a endoleak and the secondary endovascular procedure on (b)(6) 2017 (reference 2031527-2017-00693), clinical also found a complete component separation; cuff migration (1.5 cm); main body buckling; 3b of the cuff and superior stent cage dilation (28%).Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent integrity of the cuff (breached), and the main body (superior stent margin) was the use of the strata material in combination with a progressive loss of overlap, likely cause by an extreme aortic and an iliac tortuosity.The complete component separation resulted in a loss of seal.The resultant component remodeling likely caused the stent migration and near complete buckling of the main body stent.Intra-operatively, the buckling precluded the physician from performing a successful reline and an additional surgical femoral to femoral bypass (and an aui procedure) was needed to repair the system.The patient was discharged home in stable condition.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.A routine follow up showed the patient had a type 3a endoleak.The physician elected to implant a non-endologix cook device to seal the endoleak.Patient was discharge home in stable condition.Upon clinical evaluation, patient was also noted for a complete component separation; a cuff migration and main body buckling; iiib of the cuff; and superior stent cage dilation.No further information was provided.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL CUFF
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7318135
• Report Number: 2031527-2018-00153
• Device Sequence Number: 10790479
• Product Code: MIH
• UDI-Device Identifier: 00818009013545
• UDI-Public: (01)00818009013545(17)150213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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
• Operator of Device: Physician
• Device Expiration Date: 02/13/2015
• Device Model Number: A34-34/C80 V
• Device Lot Number: 1164476014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 03/06/2018
• 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: BIFURCATED STENT GRAFT, LOT 1101252-030
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR