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

Device Problem Complete Blockage (1094)

Patient Problems Occlusion (1984); Renal Failure (2041)

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 # (b)(4) renal occlusions: mfr report # 2017233-2019-00942.Event # (b)(4) patient 2 sma and celiac occlusion: mfr report # 2017233-2019-00952.Event # (b)(4) infection without identified patient: mfr report # 2017233-2019-00953.Event # (b)(4) patient 3 renal artery occlusion and infection: mfr report # 2017233-2019-00954.Event # (b)(4) type iii endoleak with reintervention: mfr report # 2017233-2019-00955.Event # (b)(4) 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 underwent repair of a crawford type iv aneurysm with renal debranching.Five months after the procedure, both renal branches were occluded.He was placed on dialysis, which he eventually refused and was placed in hospice on comfort care.It is not known whether this patient was treated with a gore device.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9132584
• MDR Text Key: 163012351
• Report Number: 2017233-2019-00946
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR