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

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

The devices remain implanted in the patients.Please be informed that within the reviewed literature article in total two reportable type of incidents were determined.They are reported with gore reference numbers (b)(4).

Event Description

The following literature article was reviewed: "stent grafts in patients with carotid blowout syndrome: outcome and antiplatelet therapy in preventive versus emergency cases".Kornelia kreiser et al.Journal of the sciences and specialities of the head and neck, 2018;40:2521-2527.First published: august 13, 2018.This retrospective study concentrates on indications for implanting stent grafts in cases of carotid blowout syndrome for threatened, imminent and acute bleeding due to current or previous head and neck malignancies.17 patients were included from january 2010 to december 2016.Overall 19 arteries were stented in 24 procedures by using 39 stent grafts of different type from various manufacturers.Thereof 21 selfexpandable ptfe-coated nitinol stents with a heparin coating (viabahn; gore & associates, flagstaff, az) were used.Target arteries were common carotid artery, common carotid/internal carotid artery junction, internal carotid artery and subclavian artery.A long 8f - 10f sheath was inserted via transarterial access in the groin.The viabahn endoprostheses were delivered over a 0.014¿¿ or 0.018¿¿ wire.The chosen stent grafts were intentionally slightly oversized.If necessary, up to three stents were inserted that slightly overlapped.One patient, who did not receive any effective platelet inhibitors, presented with a complete local thrombotic occlusion of the stent 4 days after implantation.It was resolved by aspiration via a large lumen catheter during a reintervention.

Manufacturer Narrative

Patient age: 59 = mean age provided in the article.Patient gender: vast majority is male.Please be informed that within the reviewed literature article in total two reportable type of incidents were determined.The present one and one incident reported with gore reference number (b)(4), mfr report # 2017233-2019-00778.

Manufacturer Narrative

B3: date of event is unknown, so the publishing date was used as date of event.D6: as a best estimate the starting date of this study is used as the date of implant.G3: the event is based on a reviewed literature article.H6-code 3221: information relevant to investigate the event was requested from the author.The author apologized that neither lot#, nor patient related information, nor procedure related information can be shared with gore for data protection reasons.Without additional information, gore was unable to do further investigation of this event.The author stated that in all cases mentioned, there occured no device-related adverse events.All complications were either associated with a complex anatomical situation or a medication error.

Manufacturer Narrative

H6-code 4310: updated conclusion code.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8947978
• MDR Text Key: 160847265
• Report Number: 2017233-2019-00777
• 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
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2020

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: 08/29/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2019; 12/16/2019; 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR