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

Catalog Number JHJR080502J

Device Problem Unintended Movement (3026)

Patient Problem Pseudoaneurysm (2605)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.

Event Description

The following was reported to gore by the doctor: in (b)(6) 2018, the patient underwent endovascular repair to stop bleeding from an iatrogenic pseudoaneurysm of the superior mesenteric artery caused by a pancreatic fistula using gore® viabahn® endoprosthesis with heparin bioactive surface.At a later date implantation of a second gore® viabahn® endoprosthesis with heparin bioactive surface in the celiac area was performed, but leakage of the pancreatic juice persisted.Five months after the initial procedure ((b)(6) 2019), the origin of the superior mesenteric artery, affected by the pancreatic juice and infection, was transected from the aorta.The doctor reported the patient expired due to hemorrhage resulting from the transection of the artery.The doctor speculated to gore that the superior mesenteric artery weakened after exposure to pancreatic juice and finally transected as a result of the exposure.Additionally, the doctor speculated that the first gore® viabahn® endoprosthesis with heparin bioactive surface might have migrated during the patient¿s course but was unable to confirm.

Manufacturer Narrative

Corrected data: adverse event and/or product problem, date of event, event description.Additional manufacturer narrative: date of event: no actual event date was provided.Therefore, date of event ((b)(6) 2019) is an estimate based on the available information.

Event Description

The following was reported to gore by the doctor: on (b)(6), 2018, the patient underwent endovascular repair to stop bleeding from an iatrogenic pseudoaneurysm of the superior mesenteric artery caused by a pancreatic fistula using the gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn).It was reported, the first viabahn device did not have enough length to completely cover the target lesion.An additional gore® viabahn® endoprosthesis with heparin bioactive surface was implanted the next day, (b)(6), 2018.At a later date implantation of two additional gore® viabahn® endoprostheses with heparin bioactive surface in the celiac area was performed, but leakage of the pancreatic juice persisted.Five months after the initial procedure ((b)(6) 2019), the origin of the superior mesenteric artery, affected by the pancreatic juice and infection, transected from the aorta.The doctor reported the patient expired due to hemorrhage resulting from the transection of the artery.The doctor speculated to gore that the superior mesenteric artery weakened after exposure to pancreatic juice and finally transected as a result of the exposure.Additionally, the doctor speculated that the first gore® viabahn® endoprosthesis with heparin bioactive surface, implanted on (b)(6), 2018, in the superior mesenteric artery, might have migrated during the patient¿s course but was unable to confirm.

Manufacturer Narrative

Additional manufacturer narrative:.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8410412
• MDR Text Key: 139114642
• Report Number: 2017233-2019-00131
• 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
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JHJR080502J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death