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

Catalog Number BXA077901J

Device Problems Device Dislodged or Dislocated (2923); Incomplete or Inadequate Priming (4041)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following was reported to gore: on (b)(6) 2019, this patient underwent treatment of bilateral iliac artery lesions using gore® viabahn® vbx balloon expandable endoprosthesis with kissing stent technique.The usual way to prepare the device as stated in the instructions for use, to pull negative pressure and carefully release to neutral for contrast fill was not performed.A device was advanced over a radifocus stiff wire.A medikit 7fr x 25cm (likely but unconfirmed) sheath was advanced over the lesion, and the delivery catheter was advanced inside the sheath.After positioning of the bilateral endoprostheses, the endoprostheses were unsheathed.Just before deployment was initiated, the pulling for negative pressure step was performed and unusual blood inflow into the balloon inflation port of one device was observed.The possibility of balloon damage was suspected, and it was decided to withdraw the delivery catheter.The delivery catheter was pulled, and the edge of the endoprosthesis was caught in the tip of the sheath and became flared-out.As it became difficult to withdraw the endoprosthesis back into the sheath, the delivery catheter and the sheath were removed together.After that, it was confirmed that the endoprosthesis became dislodged from the balloon catheter and remained in the patient over a guidewire.Another balloon catheter (coyote) was advanced through the endoprosthesis, and an attempt was made to carry the endoprosthesis to the target lesion while expanding it.It was unsuccessful due to a stenotic area.Another balloon catheter (mustang) was advanced through the endoprosthesis, and the endoprosthesis was implanted in the external iliac artery.Another gore® viabahn® vbx balloon expandable endoprosthesis was advanced and deployed in kissing technique, and the procedure was completed with no further issue.

Manufacturer Narrative

H.6.Results code 2 - 213.H.6.Conclusions code 1 - 4315.Engineering evaluation: the vbx device, including the balloon and delivery catheter, is 100% verified to be leak free during the manufacturing process.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 examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Corrected data: d2: common device name.Additional manufacturing narrative: c1.Name (#1) cbas® heparin surface; manufacturer / compounder: w.L.Gore & associates, inc.Lot#: 20945830.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9452485
• MDR Text Key: 191293435
• Report Number: 2017233-2019-01234
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• 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,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Catalogue Number: BXA077901J
• Device Lot Number: 20945830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR