MAUDE Adverse Event Report: ENDOLOGIX INC. VISIFLEX; BIFURCATED

Model Number 25-16-140BL - US SUREPASS

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Hole In Material (1293); Leak/Splash (1354); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 05/12/2016

Event Type  Injury  

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.Devices remain implanted in the patient.

Event Description

The patient was initially implanted with a bifurcated stent, a suprarenal aortic extension and a limb stent on (b)(6) 2008.On (b)(6) 2016 a follow up computed tomography (ct) scan showed an unknown endoleak.The physician suspects a type 3b endoleak and slight aneurysm sac growth.The physician initially was not going to complete an endovascular repair due to the fragile nature of the patient.On (b)(6) 2016 the physician elected to reline the initial bifurcated stent and implanted an additional bifurcated stent to seal the endoleak.The patient is stable.

Manufacturer Narrative

At the completion of the investigation, the clinical evaluation was able to confirm the reported type 3b endoleak and aneurysm sac expansion.Additionally there was evidence to reasonably support the following observations; at 52 months post implant a partial stent collapse, progressive stent collapse and stent movement of the infrarenal cuff.The clinical assessment was based on no medical records and suboptimal patient images.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The root cause of the reported event is unknown, there is not enough information to determine the root cause of the reported event.The event devices remain implanted in the patient and were not returned for further evaluation.The clinical evaluation was unable to identify any potential contributing factors to the reported event due to the limited patient information available.

• Brand Name: VISIFLEX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5992507
• MDR Text Key: 56094801
• Report Number: 2031527-2016-00464
• Device Sequence Number: 1
• Product Code: MIH
• 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: 08/01/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: 25-16-140BL - US SUREPASS
• Device Lot Number: W08-1093-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 10/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2008
• 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
• Treatment: LIMB EXTENSION- W08-0765-007; SUPRARENAL AORTA UNI-ILIAC- W08-0248-004
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR