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

Catalog Number BXA077901J

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

The devices remain implanted in the patient, therefore they are not available for direct product analysis.Reference medwatch # 2017233-2020-00435 for other device.

Event Description

Following was reported to gore.On (b)(6) 2020, a patient underwent endovascular treatment of occlusion of the aorta and bilateral iliac arteries using gore® viabahn® vbx balloon expandable endoprosthesis(vbx).It was reported that the iliac arteries were highly calcified, and that the two vbx were placed by kissing stent technique.It was not reported which vbx were placed at which side.The procedure was completed without any issues.In mid (b)(6) 2020, the patient complained pain on the left leg, and she reported that the pain had recurred approximately two weeks after the initial procedure.An examination imaging revealed the vbx at the left common iliac artery was compressed and almost occluded.On (b)(6) 2020, a reintervention was performed.The vbx was relined using two additional stent grafts.The patient tolerated the procedure.The physician reported that the vbx might have been compressed by spine since the patient has a strong tendency to bend forward when standing position.

Manufacturer Narrative

Corrected data: h6.Results code 1.H6.Conclusions code 1.Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.

Manufacturer Narrative

Additional manufacturer narrative: gore does not know which bxa085901j (lot #21632338 or lot #21632340) was implanted in the left iliac artery.Therefore, two medwatch reports have been submitted - reference medwatch #2017233-2020-00435 for the first device report.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #21632340.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Corrected data: conclusions code 1.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10156034
• MDR Text Key: 195236956
• Report Number: 2017233-2020-00436
• Device Sequence Number: 1
• Product Code: PRL
• 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,Followup,Followup
• Report Date: 08/20/2020

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: 12/04/2022
• Device Catalogue Number: BXA077901J
• Device Lot Number: 21632340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/30/2020; 07/27/2020; 07/30/2020; 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other