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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Presentation citation: 48th annual meeting of the japanese society of interventional radiology.The date the presentation was held (b)(6) 2019, and is being used as the date of event.Additional reports are being sent to cover the reportable events in this article: 42676 - occlusion mfr# 2017233-2019-01061.42677 - occlusion mfr # 2017233-2019-01062.

Event Description

The following was presented at ¿48th annual meeting of the japanese society of interventional radiology,¿ which was held in (b)(6), on (b)(6) 2019.Presentation title: "early and midterm result of vessel trauma repair using gore® viabahn® endoprosthesis in 15 patients".The aim was to present early and midterm results of treatment of 15 patients with vessel trauma using gore® viabahn® endoprosthesis.Target patients: 15 patients (treatment region was 16), who were treated vessel trauma using gore® viabahn® endoprosthesis during january, 2017 to december, 2018.Male 11, female 4, average age 70.5.Results: the breakdown of the treatment region (vessel trauma region) was the splanchnic region (9 patients, 10 regions), the upper extremity artery (3 patients, 3 regions) and the lower extremity artery (3 patients, 3 regions).It was confirmed operation success and clinical success for all patients.The average operation time was 42 minutes.There were no patients observed with an endoleak post operation.Regarding one patient, it was observed an abscess in hematoma code 2203-a:-other near the endoprosthesis.On post operation date (pod) 56, the endoprosthesis was removed.The antiplatelet agent administrated for 14 of 15 patients post operation.Conclusion: the treatment using gore® viabahn® endoprosthesis for the vessel trauma stop bleeding safe and certainly.The early and midterm result is well.However it is suggested that there is possibility the endoprosthesis is occluded regardless of administration of the antiplatelet agent.

Event Description

The following was presented at ¿48th annual meeting of the japanese society of interventional radiology,¿ which was held in japan, on june 1, 2019.Presentation title: "early and midterm result of vessel trauma repair using gore® viabahn® endoprosthesis in 15 patients".The aim was to present early and midterm results of treatment of 15 patients with vessel trauma using gore® viabahn® endoprosthesis.Target patients: 15 patients (treatment region was 16), who were treated vessel trauma using gore® viabahn® endoprosthesis during january, 2017 to december, 2018.Male 11, female 4, average age 70.5.Results: the breakdown of the treatment region (vessel trauma region) was the splanchnic region (9 patients, 10 regions), the upper extremity artery (3 patients, 3 regions) and the lower extremity artery (3 patients, 3 regions).It was confirmed operation success and clinical success for all patients.The average operation time was 42 minutes.There were no patients observed with an endoleak post operation.Regarding one patient, it was observed an abscess in hematoma.On post operation date (pod) 56, the endoprosthesis was removed.The antiplatelet agent administrated for 14 of 15 patients post operation.Conclusion: the treatment for the vessel trauma using gore® viabahn® endoprosthesis provided was successful for hemostasis of all patients who were enrolled in this study.The early and midterm result is reported as well.However, it is suggested that there is possibility the endoprosthesis was occluded regardless of the administration of the antiplatelet agent.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9216584
• MDR Text Key: 165271410
• Report Number: 2017233-2019-01060
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR