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

Catalog Number BXA105901J

Device Problem Collapse (1099)

Patient Problem Rupture (2208)

Event Date 01/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment for aortic rupture repair using gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) and a gore® excluder® aaa endoprosthesis (plc271000j).The vbx devices were implanted from inside of the plc271000j which was implanted in the aorta to the bilateral iliac arteries using the kissing stent technique.On an unknown date (about 6 months ago), follow-up ct showed that the vbx device(s) implanted in the left side slightly collapsed.In july 2022 (date unknown), follow-up ct showed that the vbx device bxa105901j (20855116) implanted in the left side has collapsed.Reportedly, the patient had no symptoms and the abi was unchanged, but additional treatment is being scheduled for repair.The physician reportedly stated: the vbx device was patent without any issues when it was implanted.The latest ct showed that there was blood flow, but the vbx device has almost completely collapsed.Although the patient has no symptoms, additional treatment is being scheduled for the future.Fsa stated: the ct data showed that the aorta and the lumbar spine were quite close.It is possible that the vbx device was collapsed by the lumbar spine when the patient bent forward.Other possibilities are that the patient's lifestyle or some external pressure may have caused this event, since the patient was not turtle-backed and the collapse was found as a long-term result.Reportedly, the patient had lost weight, and i believe this also may have influenced this event.Update; july 25, 2022, additional information from the fsa was received: it was revealed that the collapsed device was identified as bxa105901j (20855116) device.Besides, bxa107901j (21863230) was implanted in the right side.Bxa105901j (20855116) and bxa103901j (20118230) devices were implanted in the left side.Only bxa105901j (20855116) was identified to have collapsed.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.

Manufacturer Narrative

(b)(4).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

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.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: PRL / 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15170754
• MDR Text Key: 297311160
• Report Number: 2017233-2022-03188
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Catalogue Number: BXA105901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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: 72 YR
• Patient Sex: Male