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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Source: journal of japan surgical association, volume 80, number 11, page 1971-1977 (published in november 2019).As the date of event is unknown the publication date 11/1/2019 will be used.(b)(4).

Event Description

The following publication was reviewed: gore viabahn stent placement for hemostasis of intractable hemorrhage in four cases.Case 1: this patient is an (b)(6) years old male.On an unknown date, subtotal stomach-preserving pancreaticoduodenectomy was performed for duodenum papilla cancer.On the 3rd day after the surgery, a pancreatic fistula was observed.Conservative treatment was performed, details not provided.On the 19th day after the surgery, bleeding from a drain was observed, and the patient¿s vital signs were diminishing.Angiography revealed a pseudoaneurysm of the common hepatic artery, and a gore® viabahn® endoprosthesis with heparin bioactive surface was implanted in the artery for hemostasis.Bleeding from the drain was stopped, and the patient¿s vital signs reportedly improved.Antiplatelet therapy was not administered as the physician was concerned about postoperative bleeding, as this was the first case of the device usage for bleeding in this hospital.The patient was monitored.On the 2nd day after the device implantation, the endoprosthesis was occluded.Blood flow in the distal organ was not impaired as there was collateral circulation.No further bleeding was observed, and the patient was discharged from the hospital 19 days after the device implantation.Please note: there was no complaint in case 2, 3 and 4.In the discussion field, the physician considered that antiplatelet therapy should have been started just after the stent-graft implantation to prevent thrombus formation.Therefore, the other 3 cases received the antiplatelet therapy after the stent-graft implantation and thrombus formation or device occlusion was not observed.

• 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: 9694385
• MDR Text Key: 187915231
• Report Number: 2017233-2020-00084
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR