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

Model Number	BXA075902A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met pre-release specifications.
Additional Manufacturer Narrative
Added pma/510(k)number.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: 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
• Report Number: 2017233-2021-01689
• Device Sequence Number: 17138815
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 03/04/2021; 03/04/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/12/2021; 04/14/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10./11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 66 KG