MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	VBJR081002A
Medical Device Problem Codes	Collapse (1099); Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Original psts event # 44892 grt 10-11 study, patient id (b)(6).Information obtained from imedidata ¿ stent placed in sma during index procedure (unknown device) compressed with reintervention required of additional stent placement in sma (unknown device).Information from study manager for the identity of the device/devices implanted within the sma was requested but no further information was obtained.
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.A review of the manufacturing records indicated the device met pre-release specifications.Due to no device return, an investigation could not be performed.
Additional Manufacturer Narrative
Revised b1 to capture adverse event - serious injury with product malfunction.Revised b5 to update event description.Revised d6a with device implantation date.Revised h6 - investigation conclusion code.Results were already reported on h10 of initial emdr for this event.
Event or Problem Description
The following information was previously reported to gore and is captured in another event: on (b)(6), 2016 patient id (b)(6), underwent treatment of a thoracoabdominal aortic aneurysm zone 3, with two conformable gore® tag® thoracic endoprostheses.Chimney technique was used with branch vessel treatment of the celiac, superior mesenteric, and right renal arteries.It is unknown what brand of stents were utilized in the branch vessels.On (b)(6) 2016 the stent utilized in the superior mesenteric artery (sma) was found to be compressed.On (b)(6) 2016 a reintervention took place whereby an additional stent was placed in the superior mesenteric artery.Additional information regarding this event was received on (b)(6) 2022 from the primary study coordinator: the stent implanted in the patient on (b)(6) 2016 in the sma which was subsequently found compressed on (b)(6) 2016 was identified as a gore® viabahn® endoprosthesis with heparin bioactive surface device.The additional stent placed on (b)(6) 2016 during the reintervention was an icast device.This case represents the new information that the unknown device previously reported under previous event above was recently found to be a viabahn.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14794768
• Report Number: 2017233-2022-03045
• Device Sequence Number: 5778905
• Product Code: NIP
• UDI-Device Identifier: 00733132623822
• UDI-Public: 00733132623822
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2019
• Device Model Number: VBJR081002A
• Device Catalogue Number: VBJR081002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 66 KG