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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

As it is unknown which device(s) may have contributed to the thrombosis, an additional gore® viabahn® endoprosthesis devices have been included in this report: (lot number unknown and udi unknown).

Event Description

The following literature article was reviewed: "uncertain patency of covered stents placed for traumatic axillosubclavian artery injury" atish chopra, md, et al.(journal of the american college of surgeons 2016;223:174e183.Published by elsevier inc.On behalf of the american college of surgeons.) revised january 22, 2016; accepted february 8, 2016.Background: traumatic axillosubclavian artery injuries (asais) are uncommon but devastating.There is increasing acceptance of covered stent use for asais.However, epidemiologic and long-term outcomes data are limited.We investigated national trends in asai management and our institutional outcomes after emergent covered stent placement and open surgical repairs for asais.Study design: a review of the national trauma data bank from 2010 to 2012 was performed for epidemiologic data.A single-center, retrospective review of consecutive patients with asais between january 2010 and august 2014 was also performed.On page 179 there is a reference to thrombus development post operation in 2 of 8 patients implanted with gore® viabahn® endoprostheses to treat concomitant subclavian and axillary artery injuries.This event will capture the patient implanted with two gore® viabahn® endoprostheses (5mm x 50mm and 8mm x 50mm) with post operative thrombus development.

Manufacturer Narrative

Added method code 2 - device disposition.The article references additional patient implanted with one gore® viabahn® endoprostheses with post operative thrombus development, reported under mfr report number: 2017233-2020-00329.

Event Description

The following literature article was reviewed: "uncertain patency of covered stents placed for traumatic axillosubclavian artery injury" atish chopra, m.D., et al.; (journal of the american college of surgeons 2016;223:174e183.Published by elsevier inc.On behalf of the american college of surgeons.); revised january 22, 2016; accepted february 8, 2016.Background: traumatic axillosubclavian artery injuries (asais) are uncommon but devastating.There is increasing acceptance of covered stent use for asais.However, epidemiologic and long-term outcomes data are limited.We investigated national trends in asai management and our institutional outcomes after emergent covered stent placement and open surgical repairs for asais.Study design: a review of the national trauma data bank from 2010 to 2012 was performed for epidemiologic data.A single-center, retrospective review of consecutive patients with asais between january 2010 and august 2014 was also performed.On page 179 there is a reference to thrombus development post operation in 2 of 8 patients implanted with gore® viabahn® endoprostheses to treat concomitant subclavian and axillary artery injuries.This event will capture the patient implanted with three gore® viabahn® endoprostheses (5mm x 50mm, 9mm x 50mm, and 8mm x 50mm) with post operative thrombus development.

Manufacturer Narrative

Additional manufacturer narrative: a total of three gore® viabahn® endoprosthesis were implanted in the patient.It is unknown which device(s) may have caused or contributed to the thrombosis, two additional gore® viabahn® endoprosthesis have been included in this report: (lot number-unknown and udi-unknown).Additional information about this event could not be obtained.As a result, no conclusion can be drawn.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: 10027148
• MDR Text Key: 194532685
• Report Number: 2017233-2020-00328
• 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,Followup
• Report Date: 07/20/2020

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: 05/05/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/08/2020; 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR