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

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/21/2022

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2022 a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was to be placed as a kissing stent to treat occlusion in the right iliac artery.After the right iliac was treated, an additional vbx device was being positioned on the left side as a kissing stent through an 8fr x 10cm terumo introducer sheath over a 0.035" stiff guide wire.As the physician was positioning the vbx device, it was observed under fluoroscopy that the vbx device had become dislodged.The undeployed device migrated to the superficial femoral artery.The patient was converted to open procedure and the vbx device was successfully removed.The patient did not experience any adverse consequences.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

Manufacturer Narrative

Revised b1/b2 to reflect that the device malfunctioned and led to a serious injury.Adverse event - yes and product problem - yes.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: 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: 13904560
• MDR Text Key: 287922536
• Report Number: 2017233-2022-02821
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female