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

Model Number	BXA057902A
Medical Device Problem Codes	Mechanical Problem (1384); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020, the patient was being treated for a thoracic aorta aneurysm using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) placed in a renal artery as a branch device.The device was advanced to the ostium of the renal artery for placement and met resistance due to the patient¿s tortuous anatomy.The physician decided to remove the device from the patient.As the device was being removed from the patient¿s body the device was attempted to be withdrawn through the sheath.The stent graft dislodged from the catheter.The physician stated the suspected cause of the catheter dislodging was the edge of the stent got caught on the edge of the sheath during withdrawal.The stent and catheter were able to be withdrawn from the patient in tandem with the sheath.Another vbx was used to complete the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
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.Engineering evaluation task was performed and the results are: the device was identified to be a 5 x 79 x 1350 mm configuration, which matches the event description.The gore® viabahn® vbx balloon expandable delivery system returned without the endoprosthesis mounted on it because of the reported event.The device arrived with an introducer sheath; however, because this is not a gore product it was not evaluated.Half of the endoprosthesis displayed stacked and bunched rings.The manufacturing process output of device profile can contribute to insertion difficulties.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.Crush force is controlled through machine maintenance and calibration.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.The withdrawal of the mounted endoprosthesis back through the introducer sheath after it has been fully introduced is warned against in the ifu.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Added a1.Pt id - (b)(6).

• 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
• MDR Report Key: 10333831
• Report Number: 2017233-2020-01060
• Device Sequence Number: 3451276
• Product Code: PRL
• UDI-Device Identifier: 00733132637454
• UDI-Public: 00733132637454
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2021

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: 05/21/2021
• Device Model Number: BXA057902A
• Device Catalogue Number: BXA057902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020; 01/05/2021
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 12/02/2020; 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention