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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2020

Event Type  Injury  

Manufacturer Narrative

The following article was reviewed "early renal function alterations in renal branches vs.Renal fenestrations - a dynamic scintigraphy based prospective study" matteo orrico, et al.Eur j vasc endovasc surg (2020) 60, 395-401 https://doi.Org/10.1016/j.Ejvs.2020.05.023 received 5 october 2019, accepted 14 may 2020, available online 11 july 2020.Patient identifier remains unknown, therefore the gore case reference number was used.Patient age was not given within the literature.Patient gender: vast majority is male.Date of the event remains unknown, therefore the date the article was first published was used.In total two reports are being submitted related to this article.Both reports refer to the same patient identifier.It remains unknown, if a gore vbx device has contributed to the reported events.Request was emailed to the corresponding author to clarify if gore vbx devices were involved in these events and to provide serial numbers, patient identifiers, date of birth, age, weight, gender, name, date of implantations/reinterventions, onset dates of the events and intra- and postprocedural dicom angiography imaging series.Answer still pending.The event description is only based on the article.The devices remain implanted in the patients.Therefore a device evaluation could not be performed.The serial number of the potentially involved gore devices remain unknown.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

Hold smp 7.28 the following article was reviewed "early renal function alterations in renal branches vs.Renal fenestrations - a dynamic scintigraphy based prospective study" matteo orrico, et al.Eur j vasc endovasc surg (2020) 60, 395-401 https://doi.Org/10.1016/j.Ejvs.2020.05.023 received 5 october 2019, accepted 14 may 2020, available online 11 july 2020.From march 2018 to june 2019, 67 patients who underwent elective fenestrated and branched endovascular aneurysm repair (f/bevar) procedures were enrolled in this study.The patients were divided into two groups according to the renal bridging component configuration (fenestration vs.Branch).The objective was to assess whether there is a difference at an early post-operative phase in renal function deterioration in patients treated with fenestrations vs.Branches.In the literature it is reported, that in 16 patients (34 renal arteries) gore® viabahn® vbx balloon expandable endoprostheses (vbx device) were used in the branch group after it became available on the italien market (note by gore: as of may, 31, 2018).In all other patients the begraft peripheral stent system (bentley) was used.Within the literature the following branch group events were reported: after 3 month a computed tomography angiography demonstrated that the renal artery and the bridging stent were occluded in one patient, due to unintentional overstenting of a big division branch of the renal artery with the bridging stent.It remains unknown, if a vbx device has contributed to these events.

Manufacturer Narrative

In total 2 reports related to the reviewed abstract are being submitted to fda: manufacturer report number 2017233-2021-01914.Manufacturer report number 2017233-2021-01915.H6-code 4111: several requests were emailed to the corresponding author to clarify if gore vbx devices were involved in these events and to provide serial numbers, patient identifiers, date of birth, age, weight, gender, name, date of implantations/reinterventions, onset dates of the events and intra- and postprocedural dicom angiography imaging series.H6-code 3221: the requested information was not provided.With no additional information provided, gore is unable to perform further investigations of the related complaints.It remains unknown if a gore device was involved in these incidents.

Manufacturer Narrative

Updated attachments - attached literature article that was reviewed."early renal function alterations in renal branches vs.Renal fenestrations - a dynamic scintigraphy based prospective study" matteo orrico, et al.Eur j vasc endovasc surg (2020) 60, 395-401.Https://doi.Org/10.1016/j.Ejvs.2020.05.023.Received 5 october 2019, accepted 14 may 2020, available online 11 july 2020.

• 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: 11738548
• MDR Text Key: 263856367
• Report Number: 2017233-2021-01915
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• 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 Sex: Male