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

Catalog Number PAH101502

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi information: (b)(4).Results: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

On (b)(6) 2016 a patient underwent treatment of a thoracoabdominal aortic aneurysm with gore® excluder® aaa endoprostheses and gore® tag® thoracic endoprostheses.A gore® viabahn® endoprosthesis with propaten bioactive surface was utilized in a chimney technique to treat the coeliac artery.On (b)(6) 2017 a compression of the coeliac artery stent was recognized.On (b)(6) 2017 an additional self expanding (lifestent) stent was implanted in the coeliac artery.The patient did well following the procedure.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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; flagstaff, AZ ; 9285263030
• MDR Report Key: 7284488
• MDR Text Key: 100509961
• Report Number: 2017233-2018-00120
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2018
• Device Catalogue Number: PAH101502
• Device Lot Number: 14573491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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: 72 YR
• Patient Weight: 65