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

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient underwent an endovascular procedure for an aneurysm of the hepatic artery that was treated with a gore® viabahn® vbx balloon expandable endoprosthesis.Reportedly the procedure was uneventful, and the aneurysm was fully excluded at the end of the procedure.On (b)(6) 2022, a dislocation of the device was noticed.It is planned to place a new stent on (b)(6) 2022.

Manufacturer Narrative

The device remains implanted, therefore an evaluation of the actual device could not be performed.Additional event information like detailed event description, serial number of the device, description of the reintervention, date of reintervention, preimplant, intra-procedural and follow-up dicom cta imaging series showing the reported issue, patient outcome, and aneurysm enlargement were requested from the physician.Several reminders have been sent.The answer is still pending.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.

Manufacturer Narrative

B5: updated event description with additional information received from the physician.H6-codes b13 and b22 and c19: the serial number of the device has been requested but, as reported to gore, could not be obtained, because the serial number could not be found in the electronic patient record.Therefore the manufacturing date and production details cannot be determined.The device remains implanted in the patient.Therefore a device evaluation could not be performed.Dicom imaging series have been requested for evaluation but, as reported to gore, could not be shared with gore.Therefore, an imaging evaluation could not be performed.

Event Description

On (b)(6) 2022, the patient underwent an endovascular procedure for an aneurysm (aneurysm sac dimensions: 33 mm x 26 mm) of the hepatic artery that was treated with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Reportedly the procedure was uneventful, and the aneurysm was fully excluded at the end of the procedure.On (b)(6) 2022, a dislocation of the device of 3-4 cm was noticed.It was reported that the proximal end of the vbx device migrated distally into the aneurysmal sac.Aneurysmal sac growth was noticed (aneurysm sac dimensions: 42 mm x 36 mm).Beside dislocation, the vbx device reportedly also seemed to have shortened a little bit "by sliding into itself".The physician suspected that the cause of the dislocation could be proximal undersizing and/or force of blood flow.On (b)(6) 2022, the patient underwent an endovascular reintervention to re-exclude the aneurysm with a further vbx device (8 mm x 39 mm) that was placed proximal from the initial vbx device.This means that the distal side of the new vbx device was placed inside the proximal end of the initial vbx device, and the proximal side of the new vbx device ends in the common hepatic artery.It was reported that the procedure was successful with exclusion of the aneurysm, and that the patient is doing fine.

Event Description

On (b)(6) 2022, the patient underwent an endovascular procedure for an aneurysm (aneurysm sac dimensions: 33 mm x 26 mm) of the hepatic artery that was treated with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Reportedly the procedure was uneventful, and the aneurysm was fully excluded at the end of the procedure.On (b)(6), 2022, a dislocation of the device of 3-4 cm was noticed.It was reported that the proximal end of the vbx device migrated distally into the aneurysmal sac.Aneurysmal sac growth was noticed (aneurysm sac dimensions: 42 mm x 36 mm).Beside dislocation, the vbx device reportedly also seemed to have shortened a little bit "by sliding into itself".The physician suspected that the cause of the dislocation could be proximal undersizing and/or force of blood flow.On (b)(6) 2022, the patient underwent an endovascular reintervention to re-exclude the aneurysm with a further vbx device (8 mm x 39 mm) that was placed proximal from the initial vbx device.This means that the distal side of the new vbx device was placed inside the proximal end of the initial vbx device, and the proximal side of the new vbx device ends in the common hepatic artery.It was reported that the procedure was successful with exclusion of the aneurysm, and that the patient is doing fine.

Manufacturer Narrative

Cause investigation and conclusion the serial number of the device has been requested but, as reported to gore, could not be obtained, because the serial number could not be found in the electronic patient record.Without a lot number or device serial number, the manufacturing date and/or production details cannot be determined and the information provided to gore cannot be connected to a specific device to review the manufacturing records.The device remains implanted in the patient.Therefore a device evaluation could not be performed.Dicom imaging series enabling direct assessment of product performance have been requested for evaluation but, as reported to gore, the images have not been released for forwarding to gore.Therefore, an imaging evaluation could not be performed.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.The reported information indicates a potential device malfunction, related to device migration and shortening, has occurred.The reported migration represents a known inherent risk in stent-graft endovascular procedures that can arise as a result of a multitude of factors, including intraprocedural technical considerations such as appropriate device sizing and overlap.Additional information obtained from the physician indicates that he suspected the cause of the device migration was related to undersizing at the proximal landing zone and/or blood flow force.Therefore, the root cause of the reported migration is consistent with unintended use error (i.E., user selects an inappropriate stent diameter for the patient (diameter too small) leading to the potential for stent migration).In the instructions for use the following is stated: warnings special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: migration; d.Sizing and selection of the gore® viabahn® vbx balloon expandable endoprosthesis aneurysmal lesions: to assure adequate anchoring, the diameter of the endoprosthesis should be approximately 5 - 20% or 1 mm larger than the healthy vessel diameter proximal and distal to the lesion.G.Deployment of the gore® viabahn® vbx balloon expandable endoprosthesis undersizing of the endoprosthesis relative to the vessel diameter may lead to endoprosthesis migration.The compliance charts, provided on the box label, are generated in idealized in vitro conditions that do not take into account in vivo characteristics of lesions, vessels and patient-to-patient variability.Therefore, the compliance chart should be used as a general guide and user should confirm stent diameter and length angiographically during and after balloon inflation and deflation." no items were available to directly evaluate product performance relative to the reported device shortening; therefore, the root cause could not 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15478817
• MDR Text Key: 300587250
• Report Number: 2017233-2022-03345
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 73 KG