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

Device Problem Insufficient Information (3190)

Patient Problem Aneurysm (1708)

Event Date 09/03/2013

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.#2017233-2020-00300 for the type i endoleak investigation.#2017233-2020-00301 for the infolding investigation.#2017233-2020-00302 for the amputation and early death investigation.#2017233-2020-00304 for the early death investigation.

Event Description

The following article was reviewed: 'outcomes of endovascular and contemporary open surgical repairs of popliteal artery aneurysm'; ying huang, m.D., phd; peter gloviczki, m.D.; gustavo s.Oderich, m.D.; audra a.Duncan, m.D.; manju kalra, mbbs; mark fleming, m.D.; william s.Harmsen, ms; and thomas c.Bower, m.D.; division of vascular and endovascular surgery and department of health science research, mayo clinic; copyright 2014 by the society for vascular surgery; http://dx.Doi.Org/10.1016/j.Jvs.2014.03.257; presented at the thirty-seventh annual meeting of the midwestern vascular surgical society, chicago, ill, september 6-8, 2013.The purpose of this study was to compare outcomes after endovascular repair and contemporary open repair of popliteal artery aneurysms.Clinical data of popliteal artery aneurysm patients treated between 2005 and 2012 was reviewed.The gore® viabahn® endoprosthesis was the device used for endovascular repair.The article reported on page 634 one early major amputation occurred.

Manufacturer Narrative

Conclusions code 1.No actual event date was provided.Therefore, date of event is an estimate based on publication date of the article.Review of the manufacturing records could not be completed 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.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10021580
• MDR Text Key: 193624824
• Report Number: 2017233-2020-00303
• 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: 05/26/2020

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: 05/04/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR