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

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  Injury  

Event Description

The following literature article was reviewed: "false aneurysms complicating internal carotid artery dissection" dominika kasprzak et al.Vascular and endovascular surgery 2019, vol.53(3) 259-263 published january 10, 2019.The aim of the single center retrospective study was to present results of treatment of 3 patients with false aneurysms complicating internal carotid artery (ica) dissection, treated with endovascular procedures.3 symptomatic patients with dissecting pseudoaneurysms were presented.In one patient two gore® viabahn® endoprostheses were used: a (b)(6) year-old female had a multi-organ injury in a traffic accident.Four days after initial invasive management she presented with left-sided hemiparesis due to a stroke.An angiographic computed tomography revealed dissection of c1 segment of the right internal carotid artery (ica), with a false aneurysm (12 mm in diameter) in the extracranial segment of the artery and a second one (4 mm) in the petrous (c2) segment.The dissection of the left ica with a false aneurysm was also detected.Based on these findings, a two-staged endovascular intervention was performed.First procedure on the right side: the procedure was performed under general anesthesia 3 weeks after the accident.A gore® viabahn® endoprosthesis (6 mm x 5 cm) was deployed in the extracranial segment of right ica, and then braided self-expanding leo balt stent (3.5 mm x 25 mm, balt extrusion) was used, covering the second aneurysm.The final angiogram confirmed good flow.Second procedure on the left side: nine days after the first procedure, the dissection of the left ica with false aneurysm was treated using a gore® viabahn® endoprosthesis (6 mm x 5 cm) was performed on the left ica.Three years after the procedure, doppler ultrasonography examination revealed a stenosis (>70%) in the stent placed in the right ica requiring angioplasty.The observation time of this patient was 8 years and 2 months.All 3 stents are patent, and aneurysms are occluded.The patient is functioning well, with almost no visible signs of underwent stroke.

Manufacturer Narrative

B3: date of event is unknown, so the publishing date was used as date of event.D6: date of implant is unknown, so the publishing date minus 3 years was used as date of implant.H6-code 4119: the lot numbers have not been provided.H6-code 3221: review and analysis of all available information fails to indicate a potential root cause of the incident as reported to gore, as the lot numbers remain unknown and the devices remain implanted in the patient.Multiple attempts were made to obtain additional information about this event but no additional information was received.Without additional information, gore was unable to do further investigation of this event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9100212
• MDR Text Key: 159579142
• Report Number: 2017233-2019-00877
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/02/2019

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: 09/20/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 26 YR