MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-60/I16-40
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An afx abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Upon retraction of the contralateral wire of the afx system, the physician was met with resistance.The limb cap was observed to be hitting the sheath, so a sheath dilator was inserted over the wire, and the physician attempted to pull back and remove the limb cap.This lead to the contralateral sheath being crushed.A hematoma formed on the access site due to this.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the reported difficult to withdrawal of the contralateral wire was found to be unknown/undetermined due to the lack of relevant medical records and imaging surrounding the event.The difficult retraction of the contralateral wire lead to the reported damage of the non-endologix introducer sheath and hematoma.Unable to determine procedure-related, anatomy-related and user-related issues, off label, or cautionary product use conditions.The final patient disposition was reported as no additional negative sequelae.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6955516
• Report Number: 2031527-2017-00531
• Device Sequence Number: 13639428
• Product Code: MIH
• UDI-Device Identifier: 00818009010193
• UDI-Public: (01)00818009010193(17)200207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2020
• Device Model Number: BA22-60/I16-40
• Device Lot Number: 1652492009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2017
• Supplement Date Received by Manufacturer: 09/17/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR