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

Model Number	BXA083902A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
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.Review of manufacturing device records are currently underway; balloon & catheter were returned and currently being evaluated.
Event or Problem Description
During a procedure to treat a fistula in the patient's left cephalic vein outflow stenosis, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted at the intended treatment site.After deployment, the balloon could not be deflated.As a result, balloon was overinflated in order to burst the balloon.The balloon and catheter were then removed with no harm to the patient.
Additional Manufacturer Narrative
Patient weight was requested but not made available.Code 213: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Engineering evaluation: the returned specimen was identified to be an 8 x 39 x 1350 mm configuration.The gore® viabahn® vbx balloon expandable delivery system was returned without the endoprosthesis mounted on it because it was successfully deployed.The delivery catheter displayed kinks at 18.5, 76, and 123.5 cm from the proximal end of the delivery system.The delivery catheter lot met specifications for tensile strength.The catheter of the vbx delivery system is 100% inspected at the end of the manufacturing process for any mechanical damage, including kinks.Each device is 100% verified in process to inflate and deflate.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.D1/d2 was corrected.

• 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: 10590522
• Report Number: 2017233-2020-01297
• Device Sequence Number: 19110500
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 07/11/2022
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 02/15/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR