MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 11/29/2015

Event Type  Injury  

Manufacturer Narrative

No specific device information was provided.Therefore, review of the manufacturing records could not be performed and no udi is available.The device was not returned.Consequently, 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

During review of the article (accepted manuscript: authors: f.Pedersoli, p.Isfort, s.Keil, f.Goerg, m.Zimmermann, m.Liebl, m.Schulze-hagen, m.Schmeding, c.K.Kuhl, p.Bruners; stentgraft implantation for the treatment of postoperative hepatic artery pseudoaneurysm; cardiovas intervent radiol (2016) 39:575-581, doi 10.1007/s00270-015-1274-1.It was observed in case #10 a reintervention was necessary 6 days post implant of the gore® viabahn® endoprosthesis because of hemodynamically significant rebleeding.Angiography revealed a pseudoaneurysm arising from the proximal edge of the gore® viabahn® endoprosthesis, which was successfully treated with an additional proximally overlapping gore® viabahn® endoprosthesis.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6056029
• MDR Text Key: 58357378
• Report Number: 2017233-2016-00822
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• 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 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): Required Intervention
• Patient Age: 57 YR