MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Model Number BXA075902A

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2020 a patient underwent aortic aneurysm treatment within the tambe 1701 clinical study.Two gore® viabahn® vbx balloon expandable endoprosthesis were utilized in the superior mesenteric artery (sma).On (b)(6) 2021 sma stenosis was reported.

Manufacturer Narrative

D.10.As it is not known which device was involved, or if both were involved, the following device is also being investigated: bxa075902a sn: (b)(6), udi: (b)(4).

Event Description

On (b)(6) 2020 a patient underwent aortic aneurysm treatment within the tambe 1701 clinical study.Two gore® viabahn® vbx balloon expandable endoprosthesis were utilized in the superior mesenteric artery (sma).On (b)(6) 2020, the mesenteric artery circulation was evaluated with pulse wave doppler and color flow duplex imaging.The sma was found to be patent with normal flow velocities and doppler profile.On (b)(6) 2021 sma stenosis was reported.This was described as hemodynamically significant (>70%).This was treated by means of angioplasty.On (b)(6) 2021 the mesenteric artery circulation was evaluated with pulse wave doppler and color flow duplex imaging.This showed a patent sma with normal flow velocities and doppler profile.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met pre-release specifications.

Manufacturer Narrative

Added pma/510(k)number.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11355581
• MDR Text Key: 232811243
• Report Number: 2017233-2021-01689
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: BXA075902A
• Device Catalogue Number: BXA075902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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
• Treatment: SEE H.10./11.
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 66 KG