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

Model Number	BXA095901A
Medical Device Problem Codes	Malposition of Device (2616); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
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
The following was reported to gore: on (b)(6) 2021 a patient presented with stenosis in the right external iliac artery and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.The physician was using an 8fr terumo sheath to advance the vbx device.After exiting the sheath, which reportedly had no observable kinks at time of insertion, the physician noticed the vbx device had become dislodged from the delivery catheter.The physician then deployed the dislodged vbx device in the right external iliac artery, which reportedly resulted in unintentional coverage of the right internal iliac artery.The patient tolerated the procedure and there was no patient sequelae from the event.The physician had no speculation on what could have caused the vbx device dislodgement.The delivery system will be returned to gore.
Additional Manufacturer Narrative
H6: health impact code 4650 used to represent unintentional obstruction of vessels.A review of the manufacturing records indicated the device met all pre-release specifications.The returned device was confirmed as the delivery system (80 cm) for a gore® viabahn® vbx balloon expandable endoprosthesis (9 x 59 mm) device.The vbx delivery system was returned with no endoprosthesis present (as reported, the endoprosthesis remains implanted).It appeared the vbx device had not been deployed, as witness marks, i.E., an impression from the previously placed endoprosthesis, are visible on the balloon cover.The delivery system was otherwise unremarkable.The root cause of endoprosthesis dislodgement could not be established based on the information provided, including evaluation of the returned delivery system.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12647751
• Report Number: 2017233-2021-02474
• Device Sequence Number: 1295631
• Product Code: PRL
• UDI-Device Identifier: 00733132637362
• UDI-Public: 00733132637362
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2022

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: 11/26/2022
• Device Model Number: BXA095901A
• Device Catalogue Number: BXA095901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 05/02/2022; 05/02/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 05/04/2022; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male