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

Catalog Number BXA093902E

Device Problems Positioning Failure (1158); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device was discarded at the facility.An engineering evaluation without returned devices is being conducted.Results pending.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

A few week ago, on unknown exact date, the patient underwent a staged branched endovascular aortic repair procedure with zenith® t-branch® thoracoabdominal endovascular graft (cook medical).All bridging stents to the visceral vessels were gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device).The celiac artery was not stented during initial procedure, to allow collateral vessels in lumbar region to develop and perfuse.On (b)(6) 2020, the second intervention to treat the celiac artery with a viabahn vbx device was done successfully.On (b)(6) 2020, an endovascular reintervention was required because of a type 1c endoleak from the viabahn vbx device placed in the superior mesenteric artery.The physician suspected, that the endoleak developed because of undersizing during the initial procedure.They proceeded to extend the sealing zone with a viabahn vbx device, tracking from the femoral artery over an amplatz wire, through an aptus 16f sheath (medtronic).Reportedly, the physician felt too much resistance, because the angle was steep to pass over at top of sheath.Therefore they withdrew the viabahn vbx device.Then they tried with an atrium advanta v12 balloon expandable covered stent (getinge) and then they tried with a fluency¿ plus endovascular stent graft (bard), but with no success.After this they noticed a dislodged stent inside the sheath at the level of aortic bifurcation.They checked all the withdrawn stents and realized, that the viabahn vbx endoprosthesis was not on the delivery catheter.The viabahn vbx endoprosthesis was removed from the patient in an undeployed state.They used a snare catheter to secure the viabahn vbx endoprosthesis and removed through the sheath.Another viabahn vbx device was used to complete the intervention successfully with no further issues.It was stated, that the patient is doing fine.

Manufacturer Narrative

H6-code 213: the device was discarded at the facility.Therefore the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.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.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: 10440562
• MDR Text Key: 204408438
• Report Number: 2017233-2020-01144
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: BXA093902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization