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

Model Number BXA083902A

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2020

Event Type  malfunction  

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 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.

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
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10590522
• MDR Text Key: 208787143
• Report Number: 2017233-2020-01297
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 02/15/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR