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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the lot number remains unknown.Multiple attempts have been made to get additional information from the author.As no information related to this complaint has been or will be provided by the author, this event will be closed with the information received.Date the incident occurred is unknown, so the date of publication of the article was used as the incident date.(b)(4).

Event Description

Within the article ¿aortic arch hybrid repair: stent-bridging of the supra-aortic vessel anastomoses (savsteb)¿, published by maximilian pichlmaier et al, within the annals of thoracic surgery 2017, accepted for publication on august 4, 2017, the article results indicate the following: the article describes a technique (supra-aortic vessel anastomosis stent bridging; savsteb) and our early clinical experiences, which considerably simplifies the creation of the anastomoses to left subclavian and left common carotid arteries.Between november 2012 and november 2016, 31 patients underwent the savsteb modification of the frozen elephant trunk procedure.Among those patients, 10 had aneurysmal disease, 7 had chronic aortic dissection, and 14 had acute aortic dissection.One vessel was treated by savsteb in 14 patients and two vessels in 17 patients.Left subclavian anastomosis was bridged in 26 patients and left carotid artery in 22 patients.Perioperative technical complications were observed in 1 patient with occlusion of an accidentally overstented vertebral artery origin.Within the total experience of 17.8 stent-years no bleeding issues, no embolism, no occlusions, no migrations, no erosions, no stent fractures, and no target vessel kinking or stenoses were observed.

• 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: barbara ulrich ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8011904
• MDR Text Key: 125278893
• Report Number: 2017233-2018-00656
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• 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): Other
• Patient Age: 63 YR