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

Model Number	BXAL083901A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, a patient presented for treatment of a stenotic brachial cephalic artery that was heavily calcified.A carotid artery cut-down was performed and an 8fr terumo pinnacle sheath was placed.Through the 8fr sheath, an 8lmm x 39mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was inserted over a 0.035v stiff wire.The vbx device was deployed at the treatment site.During withdrawal of the balloon catheter through the sheath, resistance was felt.When the catheter was removed from the sheath, it was noticed the distal balloon cover had inverted towards the deployment hub.On the back table, the scrub technician pulled on the side that was still attached, and completely detached the balloon cover.As reported, the sheath may have contributed to the detachment of the balloon cover while catheter was being pulled back through the sheath.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Review of device manufacturing record history confirmed device met pre-release specifications.Affected balloon was returned; results pending completion of investigation.Stent device remains implanted.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
E1: facility name was added.
Additional Manufacturer Narrative
E1: correction to spelling of facility name, b4: update to event description (anatomical location).
Event or Problem Description
On (b)(6) 2022, patient presented for treatment of a stenotic brachiocephalic artery that was also very calcified.A carotid artery cut-down was performed and an 8fr terumo pinnacle sheath was placed.Through the 8fr sheath, an 8lmm x 39mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was inserted over a 0.035v stiff wire.The vbx device was deployed at the treatment site.During withdrawal of the balloon catheter through the sheath, resistance was felt.When the catheter was removed from the sheath, it was noticed the distal balloon cover had inverted towards the deployment hub.On the back table, the scrub technician pulled on the side that was still attached, and completely detached the balloon cover.As reported, the sheath may have contributed to the detachment of the balloon cover while catheter was being pulled back through the sheath.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
H6: code c070603: the engineering evaluation summary states: the reported difficulty withdrawing the device through the introducer sheath could not be independently confirmed through evaluation of the returned items.However, engineering evaluation confirmed the balloon cover separation which is consistent with the reported withdrawal difficulty.The 8 fr sheath reportedly used during the procedure is larger than the size recommended for this device (7 fr) in the device instructions for use (ifu).The cause for the balloon cover separation could not be established with the available information.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15617354
• Report Number: 2017233-2022-03412
• Device Sequence Number: 5798141
• Product Code: PRL
• UDI-Device Identifier: 00733132637812
• UDI-Public: 00733132637812
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2025
• Device Model Number: BXAL083901A
• Device Catalogue Number: BXAL083901A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 11/17/2022; 12/05/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 10/26/2022; 11/18/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2022
• 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: A
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female