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

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2019, the patient was implanted with a gore® viabahn® vbx balloon expandable endoprosthesis in the subclavian vein to treat vessel stenosis.On (b)(6) 2020, imaging identified the device had migrated an unknown amount.Imaging also identified compression of the device.The physicians suspected cause of the movement and compression is the patients arm movement.No reintervention has been scheduled or performed at this time.

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: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Crush resistance of the vbx device can be influenced by the stent ring material, stent ring geometry, stent ring spacing, and stent ring alignment.The stent rings are certified by the supplier for the material and geometric properties.Stent rings are 100% verified during the manufacturing process to be free of visual deformities.Stent ring geometry, spacing, and alignment are 100% verified during the manufacturing process.The device history file was reviewed and no anomalies were identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 10330527
• MDR Text Key: 200628322
• Report Number: 2017233-2020-01058
• Device Sequence Number: 1
• Product Code: PRL
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1