MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number PLC161400J

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/16/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses (b)(4).The stent grafts were deployed in a crossing-leg fashion, and an intra-procedure imaging revealed a suspected proximal type i endoleak.Two aortic extender components were implanted to treat the endoleak, and the procedure was concluded with the endoleak almost all resolved.On (b)(6) 2015, a follow-up imaging revealed a persistent endoleak.When the physician reviewed intra-procedure images taken during the initial procedure, it was revealed that the ipsilateral leg of the (b)(4) had been deployed, pushing up the (b)(4), which had caused it to be almost detached from the contralateral gate.Also, it was revealed that the persistent endoleak was a type iii endoleak.On (b)(6) 2015, another contralateral leg component was implanted to bridge the contralateral gate and the detached (b)(4).The type iii endoleak was resolved, and the patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

Describe event or problem additional information was obtained and the event description was corrected.

Event Description

On (b)(6) 2015, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore excluder aaa endoprostheses (rlt231418j/13549906 and plc161400j/13272921).The stent grafts were deployed in a crossing-leg fashion, and an intra-procedure imaging revealed a suspected proximal type i endoleak.Two aortic extender components were implanted to treat the endoleak, and the procedure was concluded with the endoleak almost all resolved.On (b)(6) 2015, a follow-up imaging revealed a persistent endoleak.When the physician reviewed intra-procedure images taken during the initial procedure, it was revealed that the ipsilateral leg of the rlt231418j had been deployed, pushing the plc161400j outward, which had caused it to be almost detached from the contralateral gate.Also, it was revealed that the persistent endoleak was a type iii endoleak.On (b)(6) 2015, another contralateral leg component was implanted to bridge the contralateral gate and the detached plc161400j.The type iii endoleak was resolved, and the patient tolerated the procedure.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4920365
• MDR Text Key: 6016145
• Report Number: 3007284313-2015-00072
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• 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: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: PLC161400J
• Device Lot Number: 13272921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• 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: (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR