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

Catalog Number BXAL082902E

Device Problem Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

The device remains implanted, so that a further device investigation cannot be performed.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The study investigator stated that in this case on the 7th of october 2020, further migration of the cook fenestrated main body was prevented by placing endo anchors.The configuration of the bridging stents looked fine so no relining had to be performed and the patient is doing fine now.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

A study alert was received from imedidata database.The patient referenced in this event file is enrolled in a registry which has been designed with broad eligibility criteria to capture real-world gore® viabahn® vbx balloon expandable endoprosthesis use, in multiple pathologies and in conditions needing preservation of peripheral vessels.It was reported to gore that patient underwent endovascular treatment on june 19, 2019 for a pararenal aneurysm.A four times fenestrated endovascular aortic repair (fevar) was performed with a cook zfen graft as main aortic body and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) implanted each in the celiac artery, in the right and left renal artery and in the superior mesenteric artery.It was stated that on (b)(6) 2020 migration of the cook zfen main body endoprosthesis 4fevar has taken place.Reportedly, on (b)(6) 2020 three endovascular repeat interventions had to be done in the right and left renal artery and in the superior mesenteric artery due to the migration of the cook zfen main body endoprosthesis 4fevar.The patient tolerated the procedure.

Manufacturer Narrative

Corrected data: h1 / h2 type of reportable event: instead of serious injury it must be "other".H6 - investigation findings code 1.H6 - investigation conclusions code 1.Correction: further information from the study coordinator revealed that in this case on october 7, 2020, further migration of the cook fenestrated body was prevented by placing endo anchors.The configuration of the bridging stents looked fine so no relining had to be performed and the patient is doing fine now.Furthermore, it was stated that the vbx-devices were neither stenosed nor that they haven't lost their patency due to the cook main body migration requiring reintervention.According to a patient safety specialist there are no allegations on device failures on our gore® viabahn® vbx balloon expandable endoprostheses anymore.Therefore, this event is not reportable to the fda and is retracted.

• 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
• MDR Report Key: 11538694
• MDR Text Key: 241433998
• Report Number: 2017233-2021-01783
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132636914
• UDI-Public: (01)00733132636914(17)211108
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Catalogue Number: BXAL082902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK ZFEN MAIN BODY ENDOPROSTHESIS 4FEVAR; COOK ZFEN MAIN BODY ENDOPROSTHESIS 4FEVAR
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR