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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 09/24/2017

Event Type  Injury  

Manufacturer Narrative

The section were completed with the provided mean age and mean gender of the article.Section was completed with the date when the article was accepted as individual date of event was not stated in article.Viabahn stent for hemodialysis shunt: efficacy, long segment recanalization and prognostic factors for reintervention, published by giancarlo salsano et al, published in the journal of vascular access 2018, vol.19(1)76-83.

Event Description

Within the article ¿viabahn stent for hemodialysis shunt: efficacy, long segment recanalization and prognostic factors for reintervention¿, published by giancarlo salsano et al, within the journal of vascular access, the article indicates the following: the study evaluated the heparin bioactive surface (hbs) viabahn stent efficacy in the maintenance or re-establishment of hemodialysis.In total 50 viabahn stents deployed in 37 consecutive patients with hemodialysis dysfunction from january 2008 to may 2016 were evaluated in a single-institution retrospective review.In our series, 23 patients underwent multiple endovascular procedures after the stent placement in the whole period of follow-up.The endovascular procedures included angioplasty, thrombo-aspiration and a second viabahn stenting.The article describes a single case of infection of avg by staphylococcus aureus occurred three months after the stent placement.

Manufacturer Narrative

Code correction for previous reported ¿result code 1¿ 142.The code was exchanged to 3221.¿conclusion code 1¿ was also exchanged from 11 to 4315.Added another "method code 1".

Manufacturer Narrative

Multiple attempts have been made from the gore associate to the complainant in order to get additional information.As no further information related to this complaint will be provided by the complainant, this event will be closed with the information received.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10023272
• MDR Text Key: 194322003
• Report Number: 2017233-2020-00311
• 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,Followup
• Report Date: 07/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR