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

Device Problem Separation Failure (2547)

Patient Problem Pseudoaneurysm (2605)

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.

Event Description

The following information was obtained at the 14th (b)(6) endovascular symposium: on an unknown date, the patient underwent endovascular treatment using two non-gore stent graft (graftmaster 2.8 x 16 mm, 3.5 x 16 mm) for right posterior tibial pseudoaneurysm.During the procedure, a proximal type i endoleak of non-gore stent graft was observed.To treat the endoleak, a gore® viabahn® endoprosthesis (5.0 x 25 mm) was deployed proximally.Then, the stent graft did not fully open, and stuck on the leading olive.The physician was unable to remove the delivery catheter.The physician attempted to remove the delivery catheter using a balloon anchor, however it was unsuccessful.The physician fixated the stent using a guide wire and the delivery catheter was removed.An additional stent graft was deployed on the proximal side.The final angiography showed blood flow distally and the aneurysm diameter tended to decrease.The patient tolerated the procedure.On an unknown date, five months after the initial procedure, it was noted that the stent grafts were occluded.The physician is monitoring the patient.The physician stated: an oversized stent graft was selected.(the blood vessel diameter unknown).The ballooning before the deployment was insufficient.The physician understood the site was outside of ifu, but it was an emergency procedure.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8967930
• MDR Text Key: 158647209
• Report Number: 2017233-2019-00807
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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 Age: 82 YR