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

Catalog Number RLT311413J

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to: endoleak.

Event Description

On (b)(6) 2016, the patient underwent treatment of an abdominal aneurysm with gore® excluder® aaa endoprostheses.There was no endoleak observed and the patient tolerated the procedure.On (b)(6) 2016 a computed tomography scan indicated a suspected type iii endoleak.On (b)(6) 2016, the patient underwent the secondary intervention to treat the endoleak.An angiography identified the endoleak was proximal type i from a trunk-ipsilateral component rlt311413j.The rlt311413j lost its proximal wall apposition.The physician performed ballooning inside the rlt311413j, however, the endoleak was not resolved.The physician implanted an aortic extender component proximal to the rlt311413j and performed ballooning again.The proximal type i endoleak was resolved.Then an angiography identified there was a distal type i endoleak from a contralateral leg component plc231200j.The physician performed ballooning inside the plc231200j, however, the distal type i endoleak was not resolved.The physician implanted another contralateral leg component distal to the plc231200j covering the right internal iliac artery.The distal type i endoleak was resolved.It was reported that the proximal neck was highly angulated and this might have contributed to lack of wall apposition causing the proximal type i endoleak.

Manufacturer Narrative

Corrected.

• 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: izumi ishikawa ; 9285263030
• MDR Report Key: 6185030
• MDR Text Key: 62701151
• Report Number: 3007284313-2016-00255
• 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: 03/02/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2018
• Device Catalogue Number: RLT311413J
• Device Lot Number: 14564914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR