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

Catalog Number BXA077901J

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Occlusion (1984)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The second device is being reported under mfr.Report # 2017233-2020-00081.

Event Description

The following information was reported to gore: on (b)(6) 2020, this patient underwent endovascular treatment of an iliac artery stenotic occlusion using three gore® viabahn® vbx balloon expandable endoprosthesis for leriche syndrome, also known as aortoiliac occlusive disease.Two vbx devices were deployed in the aortic bifurcation using the kissing stent technique.Another vbx was deployed to extend the left device distally.It was reported that the left popliteal artery was embolized by floating mural thrombus.Thrombus aspiration was performed, and patency was confirmed.The patient tolerated the procedure.On (b)(6) 2020, computed tomography scan image revealed a suspected occlusion.On (b)(6) 2020, the patient underwent a reintervention to treat the occlusion.Angiography and ivus revealed collapse of the two vbx implanted in the aortic bifurcation using the kissing stent technique.Poba was performed on the collapsed part.The patient tolerated this procedure.The physician stated following: it is speculated that the root cause of the device collapse is the patient's bent waist posture.The ct examination was performed although the patient¿s abi etc.Had not dropped, but the physician was not at ease about the patient's posture during hospitalization.The patient and their family were instructed to correct her posture.The fsa stated: same as the physician's view, the bend in the patient's waist may be the cause.At the time of reintervention, it was planned to deploy a bare metal stent after poba, but only ballooning was performed, because additional treatment could be performed if collapse occurred again.

Event Description

The following information was reported to gore: on (b)(6) 2020, this patient underwent endovascular treatment of an iliac artery stenotic occlusion using three gore® viabahn® vbx balloon expandable endoprosthesis for leriche syndrome, also known as aortoiliac occlusive disease.Two vbx devices were deployed in the aortic bifurcation using the kissing stent technique.Another vbx was deployed to extend the left device distally.The patient tolerated the procedure.On (b)(6) 2020, computed tomography scan image revealed a suspected occlusion.On (b)(6) 2020, the patient underwent a reintervention to treat the occlusion.Angiography and ivus revealed collapse of the two vbx implanted in the aortic bifurcation using the kissing stent technique.Poba was performed on the collapsed part.The patient tolerated this procedure.The physician stated following: it is speculated that the root cause of the device collapse is the patient's bent waist posture.The ct examination was performed although the patient¿s abi etc.Had not dropped, but the physician was not at ease about the patient's posture during hospitalization.The patient and their family were instructed to correct her posture.The fsa stated: same as the physician's view, the bend in the patient's waist may be the cause.At the time of reintervention, it was planned to deploy a bare metal stent after poba, but only ballooning was performed, because additional treatment could be performed if collapse occurred again.

Manufacturer Narrative

Event updated.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.Method code 2 added.Results code 2 added.Conclusion codes updated.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9689029
• MDR Text Key: 187931348
• Report Number: 2017233-2020-00079
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Catalogue Number: BXA077901J
• Device Lot Number: 20382443
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/04/2020; 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 87 YR