MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The devices were not returned.Consequently, direct product analysis was not possible.Additional information about these events 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.Note: no actual event date was provided.Therefore, date of event is an estimate based on publication date of the article.Note: no actual patient age was provided.Therefore, age at time of event is an estimate based on the average age identified in the article.(b)(4).

Event Description

The following information was obtained through literature review: t, abe., et al (may, 2018)."treatment results using gore® acuseal vascular graft." the japanese journal of phlebology.29 (2).261.From april, 2016 to january, 2018, 32 patients underwent arterio-venous shunt procedures using gore® acuseal vascular grafts to treat renal disease.Patient demographics shows that there were 20 males and 12 females with the average age of 66.3 years old.25 patients were implanted with the gore® acuseal vascular graft in their forearms, 7 patients were in their upper arms, and loop shunt was created among 24 patients while straight-shaped shunt was among 8 patients.Treatment results show 2 patients suffered from graft infection due to dialysis puncture in case #1, case #2, infection was due to dehiscence at the graft anastomosis site.In case #1, the gore® acuseal vascular graft was totally replaced with another vascular graft while in case #2, the gore® acuseal vascular graft was partially removed to treat graft infection.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7934960
• MDR Text Key: 122788389
• Report Number: 2017233-2018-00583
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR