MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Device Problem Material Erosion (1214)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Literature citation: walker, j.Et al 2018 long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms.Journal of vascular surgery feb.2019: 341-347.The date the article was accepted, (b)(6) 2018 is being used as the date of event.A total of 6 reports are being sent to cover the reportable events in this article event # 42218 renal occlusions: mfr report # 2017233-2019-00942.Event # 42617 patient 2 sma and celiac occlusion: mfr report # 2017233-2019-00952.Event # 42618 infection without identified patient: mfr report # 2017233-2019-00953.Event # 42619 patient 3 renal artery occlusion and infection: mfr report # 2017233-2019-00954.Event # 42620 type iii endoleak with reintervention: mfr report # 2017233-2019-00955.Event # 42622 patient 1 bilateral renal occlusion: mfr report # 2017233-2019-00946.

Event Description

The following information was reported to gore: in an article titled "long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms" it states gore® viabahn® endoprostheses were utilized in some cases as well as non-gore devices.Complications potentially related to the branch devices (either gore or non-gore) included the following: one patient had a type iii endoleak due to fabric erosion which resulted in relining of the celiac and sma branches with covered stents.It is not known whether this patient was treated with a gore stent.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9132578
• MDR Text Key: 164107514
• Report Number: 2017233-2019-00955
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other; Required Intervention
• Patient Age: 73 YR