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

Catalog Number RLT261416J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, a gore® excluder® trunk-ipsilateral leg component (rlt261416j/17633764; 16 cm overall length) was implanted as part of an endovascular aortic repair.According to the report, the treatment range from the lowest renal artery to the right internal iliac artery measured 15 cm.The proximal portion of the trunk-ipsilateral leg was reportedly deployed below both renal arteries, and the ipsilateral leg was deployed while being pushed proximally.After a contralateral leg component was advanced and deployed, a procedural angiograph reportedly revealed that both renal arteries were covered by the trunk-ipsilateral leg component.The physician attempted to pull the trunk-ipsilateral leg component distally using a balloon catheter.It was reportedly confirmed that the right renal artery was patent, but part of left renal artery ostium remained covered.Satisfactory blood flow to both renal arteries was observed, however, a metal stent was placed in the left renal artery as a precaution.The procedure was completed and the patient tolerated the procedure.

Manufacturer Narrative

Patient code: (b)(6).Device code: c62947, c62862.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7546367
• MDR Text Key: 109396936
• Report Number: 3007284313-2018-00163
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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: 01/08/2021
• Device Catalogue Number: RLT261416J
• Device Lot Number: 17633764
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR