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

Catalog Number JHJR060502J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pseudoaneurysm (2605)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

As the devices were not returned, no evaluation of the devices could be performed.

Event Description

At a poster session on (b)(6) 2019 titled ¿a case of late distal pseudoaneurysm after implantation of viabahn which repaired a pseudoaneurysm at the splenic artery developed after a surgery of the gastric cancer¿ during the 48th annual meeting of the japanese society of interventional radiology (may 30, 2019-june 1, 2019), the following case was reported; the patient was in his sixties, with a pre-existing condition of gastric cancer (stage 2), total gastrectomy, and roux-en-y reconstruction.On an unknown date 9 days post-operative of the roux-en-y reconstruction, the patient was identified with extravasation of a splenic artery, which was treated with a gore® viabahn® endoprosthesis (6mm in diameter, 5cm in length).No issues were reported during the procedure, and hemostasis was achieved.It was reported that no post-dilatation was performed to the device.The patient tolerated the procedure.On an unknown date after about 5 month post-operatively, the patient complained of difficulty in breathing, and visited the institution.A ct angiography was performed, showing accumulation of the contrast around the device, suspecting development of a pseudoaneurysm.An angiography revealed a new pseudoaneurysm distal to the device, which was repaired by coil-embolization.The new pseudoaneurysm was reportedly resolved during the re-intervention, and the patient tolerated the procedure.Post-operative ct imaging showed complete resolution of the new pseudoaneurysm.

• 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: marcos ayala ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9221630
• MDR Text Key: 175397130
• Report Number: 2017233-2019-01075
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR060502J
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR