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

Device Problems Complete Blockage (1094); Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

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, april 9, 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.(b)(4).

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: on patient underwent repair of a rapidly growing 5.8cm pararenal aneurysm.At a routine 3-year follow-up the cta showed an occluded renal branch as well as air tracking around the endoprosthesis.Aspiration of the aneurysm sac contents showed the presence of streptococcal species and bacteroides.The stent graft was explanted and the patient underwent axillobi-femoral bypasses using arterial allografts.Post-operative complications included paraplegia and respiratory failure requiring reintubation.He died two weeks after the bypass procedure of a respiratory event after choosing not to be intubated or resuscitated for any reason.It is not known whether this patient received a gore device.

• 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: 9132589
• MDR Text Key: 162993100
• Report Number: 2017233-2019-00954
• 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: 78 YR