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

Catalog Number BXA075901J

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Vascular Dissection (3160)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent an endovascular repair for peripheral artery disease in aortoiliac artery using gore® viabahn® vbx balloon expandable endoprosthesis.After the left common iliac artery stenosis lesion was pre-dilated with a balloon, the device was inserted into a terumo sheath over a 0.035 stiff wire.As the device was advanced, it got stuck at the target lesions of the left common iliac artery.The physician tried to retract the device into the sheath, it was caught by the tip of the sheath, and when it was pulled with force, the stent graft was dislodged.It fell into the external iliac artery.Also, the shaft was disengaged 3 cm from the balloon within the sheath.The sheath was removed with disengaged parts.Since it was not possible to retrieve the dislodged stent graft, stent graft was expanded with balloon and placed in the proximal of the external iliac artery.Thereafter, stent grafts were placed both in the lesion of the left and right common iliac arteries by the kissing method.The left femoral artery of the puncture site was found to be damaged and a surgical repair was performed.The physician's comment: pre-dilation was not sufficient.The sheath should have been passed to the lesion.

Manufacturer Narrative

Corrected h6: conclusion code.Corrected g5: combination product (yes).Engineering evaluation states: based on the available reported information with no device returned, the following observations were made: the manufacturing lot history files were reviewed and did not suggest any abnormalities that might have contributed to the insertion complaint.Based on this evaluation, no product design or manufacturing anomalies were detected.

Manufacturer Narrative

Engineering evaluation states: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.The device history file was reviewed and no anomalies were identified.Crush force is controlled through machine maintenance and calibration.Machine history files were reviewed and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 9221307
• MDR Text Key: 165603056
• Report Number: 2017233-2019-01074
• 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: 01/29/2020

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: 02/18/2022
• Device Catalogue Number: BXA075901J
• Device Lot Number: 20436427
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/25/2019; 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention