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

Catalog Number BXA095902E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Aneurysm (1708)

Event Date 04/13/2023

Event Type  malfunction  

Manufacturer Narrative

Product history review: a review of the manufacturing records indicated the device met pre-release specifications.Engineering evaluation: the engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.The cause for the as reported failure mode, stent dislodgement, cannot be determined based on the available information.However, the failure mode was able to be confirmed based on the returned un-expanded stent and the un-inflated state of the balloon.In addition, one row of apices was noted to be stacked on top of an adjacent row, indicating the presence of the stent stacking failure mode.A root cause for these failure modes cannot be established based on the available information, but it is likely that the event that caused the stent to dislodge contributed to the observed stent stacking.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the lot met all pre-release specifications.Cbas® heparin surface incorporates carmeda-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported to gore that the patient underwent endovascular treatment for a branched endovascular aneurysm repair (bevar) with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) in the superior mesenteric artery (sma).It was stated that a 10 fr steerable fustar sheath (lifetech scientific corp.) over a rosen guidewire was used to advance the device to the lesion.To reach the lesion a radius of 180° had to be overcome.In the curve resistance was noticed and the stent dislodged from the catheter inside the sheath.The sheath together with the device was removed from the patient.With the help of water the device was retrieved out of the sheath.The sheath was used again, and another vbx-device could be implanted successfully.There was no report of patient harm.

Manufacturer Narrative

Investigation conclusions: the primary reported failure mode concerning inability to access treatment site could not be independently confirmed during device evaluation as the clinical experience cannot be fully replicated in a laboratory environment due to in vivo characteristics (e.G., patient anatomy and disease state) that may influence advancement of the vbx device.Event details indicate resistance was noted during tracking of the device through a 180° curve to reach the lesion.However, the relationship between patient-related circumstances (i.E., vessel tortuosity), procedural circumstances (i.E., steerable sheath curved to 180°), and the reported primary failure could not be independently confirmed with the items available for review, and the root cause of the advancement failure could not be established with the available information.The reported failure mode concerning endoprosthesis dislodgement was confirmed during evaluation of the returned device.The pleated appearance of the balloon cover as well as ring impressions visible on the cover are consistent with dislodgement of the stent-graft as reported.The field reports retrieving the device from the sheath with the use of water.Therefore, the dislodgement direction could not be independently confirmed due to reported manipulation of the device within the field following dislodgement.A causal relationship between advancement of the device with resistance noticed in a curvature with a radius of 180 degrees and the reported stent dislodgement cannot be confirmed due to a lack of available information in the procedural sequence of events and their timing.Therefore, the root cause of the dislodgement cannot be established with the available information.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16901955
• MDR Text Key: 314901337
• Report Number: 2017233-2023-03919
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2024
• Device Catalogue Number: BXA095902E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10 FR STEERABLE FUSTAR SHEATH, ROSEN GUIDEWIRE
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG