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

Catalog Number ECH060040J

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

No actual explant date was provided.Therefore, explant date is an estimate based on the date identified on the photo sent to gore of the explanted device ((b)(6) 2018).The investigation is ongoing.

Event Description

On (b)(6) 2016, the patient was implanted with a gore® acuseal vascular graft in the right upper arm as an av shunt for hemodialysis.On (b)(6) 2018, a follow-up echo examination revealed thrombus and the graft appeared to be delaminated at that spot.On date unknown, 2018, re-intervention occurred removing the gore® acuseal vascular graft and replacement with the advanta¿ vascular graft.

Manufacturer Narrative

Additional manufacturer narrative: g5: combination product.Note: review of the manufacturing records verified that the lot met release requirements.

Manufacturer Narrative

Corrected data: h3: device evaluated by manufacturer? h6: results code 1.H6: results code 2.Additional manufacturer narrative: the returned specimen was examined.The graft had been transected longitudinally into 6 pieces prior to arrival at gore.Following digestion all device fragments were examined for material disruptions with the aid of a stereomicroscope.Graft fragment transections were consistent with manual manipulation by surgical instrumentation at time of explant (e.G., scissors, scalpel, razor blade) and one pole transection was made during histopathological sampling at w.L.Gore and associates using a razor blade.Areas reported as cannulation sites presented as linear to semi lunar full thickness perforations which is a typical observation in grafts implanted for hemodialysis.Areas of graft layer separation were consistently underlying and extending from sites of cannulation.Graft separation can be associated with marked cannulation sites however, areas of concentrated cannulation sites were also present with layers remaining visibly intact.Multiple variables can be introduced during the process of cannulation for hemodialysis (e.G., needle type, needle angle, repeated puncture in a focused area), and as such the exact cause of delamination cannot be determined.All information has been placed on file for use in tracking and trending.H6: conclusions code 1.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7995868
• MDR Text Key: 124714546
• Report Number: 2017233-2018-00637
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: ECH060040J
• Device Lot Number: 5105820PP020A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVANTA¿ VASCULAR GRAFT; ADVANTA¿ VASCULAR GRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR