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

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 12/29/2018

Event Type  Injury  

Manufacturer Narrative

Since no patient id is available, the gore event number was used as the patient identifier.The patient age and patient gender reflects the mean age and gender stated in the article.The date of online publication was used as the event date.Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.

Event Description

The following publication was reviewed: ¿long-term follow-up after stent graft placement for access-site and access-related vascular injury during tavi ¿ the bonn-copenhagen experience¿(alexander sedaghat et al., international journal of cardiology 281, published online 29-dec-2018).The article analyzed the outcome of 71 patients who had undergone transcatheter aortic valve implantation (tavi) between march 2010 and october 2015 with implantation of a gore viabahn® endoprosthesis (30/71) or fluency stent graft (40/71) to treat access-site or access-related vascular injury (asarvi).Implantations were mostly due to access-site bleeding complications (83.1%) in the common femoral artery (97.1%).Follow-up was performed with duplex sonography in all patients after a median of 3.9 years after tavi.The article includes the following case: a surgical intervention was necessary due to complete obstruction of the profunda femoral artery.No additional info in regards to the case was provided in the article.

Manufacturer Narrative

G5: corrected.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9108730
• MDR Text Key: 161511775
• Report Number: 2017233-2019-00889
• 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: 09/24/2019

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: 09/24/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR