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

Model Number	BXA113901A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially non-eluting.
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was intended for use in the renal vein.After the vbx device was successfully delivered, the physician was unable to fully deflate the delivery balloon after inflation to the nominal pressure of 11atm.The physician was also unable to remove or advance the.035 rosen guide wire that was used for stent delivery.The physician cut the hub off of the delivery catheter, advanced a long 8fr sheath over the balloon and successfully removed the delivery catheter and guide wire.There were no additional medical treatments necessary.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
H6 - component code added.3038 (catheter).H6 - investigation findings, updated to 3221 (no findings available).H6 - investigation findings, updated to 3221 (no findings available).H6 - investigation conclusions, updated to 4315 (cause not established).A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The delivery system for a gore® viabahn® vbx balloon expandable endoprosthesis device was returned with 0.035¿ guidewire inserted.The size of the returned vbx device could not be confirmed as neither the hub assembly nor the endoprosthesis were present.The balloon appeared to be deflated however proper inflation and deflation performance of the returned device could not be confirmed during evaluation due to the absence of the hub assembly and associated inflation lumen.The guidewire could be gently manipulated back and forth, so it did not appear to be stuck, however complete removal was not attempted.At the time of device evaluation the balloon was deflated, therefore whether the guidewire was stuck under the use conditions defined by the procedure could not be confirmed.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12162269
• Report Number: 2017233-2021-02161
• Device Sequence Number: 3530045
• Product Code: PRL
• UDI-Device Identifier: 00733132637713
• UDI-Public: 00733132637713
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: 03/09/2024
• Device Model Number: BXA113901A
• Device Catalogue Number: BXA113901A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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 Sex: Unknown