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

Catalog Number BXA083901A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records indicated the lot met pre-release manufacturing specification.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

On (b)(6), 2024, the patient underwent treatment for left lower extremity pain using a 8 mm x 39 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) in the iliac artery.It was reported the physician advanced the delivery catheter using a 7f terumo introducer sheath over an 0.035" glidewire guidewire to the target treatment site.Reportedly, the device advanced to the distal end of the sheath.Half the endoprosthesis made it out of the sheath, but it would not advance any further.The physician attempted to pull the endoprosthesis back into the sheath.The endoprosthesis accordioned, and became dislodged from the catheter.The catheter was withdrawn from the patient.Surgical cut down was performed, and the endoprosthesis was retrieved and removed.The procedure was completed with another vbx device.It was reported there was no impact to the patient other than the surgical cut down.

Manufacturer Narrative

Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.The primary reported device failure, related to advancement failure through a sheath, could not be independently confirmed as no items were returned for a direct assessment of product performance.No incompatible accessory devices were identified from the reported information, and the root cause could not be established with the available information.The reported withdrawal difficulty through a sheath and stent-graft dislodgement also could not be independently confirmed.The field reports the endoprosthesis was partially introduced outside of the sheath following advancement failure, and the stent-graft ¿accordioned¿ and dislodged during an attempt to pull the vbx device back into the sheath.An unintended device interaction occurring at the sheath interface during withdrawal could neither be confirmed nor dismissed in relation to the reported complication.Neither the withdrawal difficulty nor subsequent stent-graft dislodgement could be further evaluated with the available information, and a root cause could not be determined.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18602890
• MDR Text Key: 334025686
• Report Number: 2017233-2024-04570
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637300
• UDI-Public: 00733132637300
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA083901A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female