MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number PAH101002E

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

Date the incident occurred is unknown.Therefore the date on which the presentation was sent to gore for review was used as the date of event.The reported occlusion of the reported gore® excluder® iliac branch endoprostheses (ibe)for patient 003-011 will be reported in gore event 40643.

Event Description

A presentation with the title ¿bilateral use of the gore ibe device for bilateral cia aneurysms and a first interim analysis of the prospective iceberg registry¿ was held by (b)(6) at the linc convention on (b)(6) 2019.The presentation included initial results of the ongoing iceberg study that included 101 patients at eight international sites that were treated with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).Among other occurrences, the presentation mentions 4 early occlusions of the hypogastric branch.Additional details were not provided.The following additional info was reported to gore on may 3, 2019: (b)(6) presented with thrombosis of the ibe internal iliac component (hgb) and in addition two gore® viabahn® endoprostheses (pah), which was identified within 30 days from the implant procedure.It was stated that the patient was asymptomatic.Additionally it was reported that the hgb was extended with a pah into the internal iliac artery.An intra-procedure type iii endoleak between the two devices was solved with the implantation of a second pah.The physician assumes that the tortuosity of the vessel, the overlap of the grafts and the overlap of the devices caused excessive stiffness of the system and contributed to the occlusion.

Manufacturer Narrative

A2/3: the patient age and patient gender reflects the mean age and gender stated in the presentation.B3: the physician requested review on (b)(6) 2019.B5: the reported occlusion of the reported gore® excluder® iliac branch endoprostheses (ibe)for patient (b)(6) will be reported in event (b)(4) (mfr report# 2953161-2019-00041).G5: corrected combination product to yes.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8626665
• MDR Text Key: 145614551
• Report Number: 2017233-2019-00362
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Catalogue Number: PAH101002E
• Device Lot Number: 15528518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR