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 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: 42675 - infection mfr # 2017233-2019-01060, 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 (b)(6) 2017 to (b)(6) 2018.Male 11, female 4, average age 70.5.Results: the breakdown of the treatment region (vessel trauma region) was the splanchnic artery (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 was no patients who was observed an endoleak post operation.The antiplatelet agent was administered for 14 of 15 patients post operation.However, on pod 7, the endoprosthesis was occluded in 1 patient (2 regions, the right hepatic artery and the gastroduodenal artery).This patient was administrated the antiplatelet agent.These occlusions were asymptomatic and reportedly did not led to the organ ischemia.The patency rate was 93.3 % (11/12) at 1 month, 88.9 % (8/9) at 3 months, 83.3 % (5/6), at 6 months and 60 % (3/5) at 12 months.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.

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 artery (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 who were observed with an endoleak post operation.The antiplatelet agent was administered for 14 of 15 patients post operation.However, on post operation date (pod) 7, the endoprosthesis was occluded in 1 patient (2 regions, the right hepatic artery and the gastroduodenal artery).This patient was administrated with the antiplatelet agent.These occlusions were asymptomatic and reportedly did not lead to the organ ischemia.The patency rate was 93.3 % (11/12) at 1 month, 88.9 % (8/9) at 3 months, 83.3 % (5/6), at 6 months and 60 % (3/5) at 12 months.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.

Manufacturer Narrative

Added a1: patient identifier.Added a2: age at time of event.Added a3: gender.Corrected b5: event description.Added g4: date received by manufacturer.Corrected g5: combination product (yes).Corrected h6: method code 1 and method code 2.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9216578
• MDR Text Key: 163155800
• Report Number: 2017233-2019-01061
• 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
• Treatment: PATIENT MEDICATIONS: ANTIPLATELET AGENT.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR