MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED

Model Number	BEA25-70/I16-30
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Hematoma (1884); Ischemia (1942); Occlusion (1984); Thrombus (2101)
Date of Event	07/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the investigation, the clinical evaluation was able to confirm the contralateral limb endoknot and difficulty resolving the endoknot.Additionally, the clinical evaluation was able to confirm a type 2 endoleak.The clinical assessment was based on no medical records and adequate patient images.A manufacturing or design issue has not been identified or suspected based on the evaluation of the reported event.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 found further evidence to reasonably suggest the following contributing factors to the reported event; patient anatomy, patient history of peripheral vascular disease with calcifications in the iliacs, sheath exchanges/manipulations during resolution of the wire wrap, and angioplasty of the left iliac limb of the bifurcated device with a coda balloon might have contributed to the dissection, and subsequent negative sequelae.Devices remain implanted in the patient.
Event or Problem Description
It was reported during patient initial procedure on (b)(6) 2016 the contra-limb wire became entangled resulting in an endoknot.The physician was able to reconcile the knot which prolonged the procedure.Post procedure the patient was taken back to the operating room for an ischemic leg as well as an occluded left external iliac artery due to a dissection.The physician completed a surgical exploration of the left common femoral artery with patch angioplasty and placed stents in the left common iliac artery as well as the left external iliac artery to resolve the dissection and occlusion.His recovery was complicated by acute encephalopathy with confusion and a minimal left side retroperitoneal hematoma.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6058937
• Report Number: 2031527-2016-00497
• Device Sequence Number: 18845959
• Product Code: MIH
• UDI-Device Identifier: 00818009014870
• UDI-Public: (01)00818009014870(17)170317
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2017
• Device Model Number: BEA25-70/I16-30
• Device Lot Number: 1355831-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 10/26/2016
• 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: INFRARENAL AORTO UNI-ILIAC- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR