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

Catalog Number SGS-183L

Device Problem Partial Blockage (1065)

Patient Problem Thrombus (2101)

Event Date 12/07/2018

Event Type  Injury  

Event Description

It was reported a patient underwent a total cavopulmonary connection procedure (inferior vena cava to the pulmonary artery) with a gore tex® vascular graft on (b)(6) 2018.The patient tolerated the procedure.On (b)(6) 2018, it was reported that thrombus in the graft was observed during a re-fenestration procedure.The graft was removed and a new graft (manufacturer unknown) was implanted.The patient tolerated the procedure.On (b)(6) 2018, a follow-up revealed blood flow through the graft was stable.

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.

Event Description

It was reported a patient underwent a total cavopulmonary connection procedure (inferior vena cava to the pulmonary artery) with a gore tex® stretch vascular graft on (b)(6) 2018.The patient tolerated the procedure.On (b)(6) 2018, it was reported that thrombus in the graft was observed during a re-fenestration procedure.The graft was removed and a new graft (manufacturer unknown) was implanted.The patient tolerated the procedure.On (b)(6) 2018, a follow-up revealed blood flow through the graft was stable.

Manufacturer Narrative

5.Describe event or problem - corrected gore-tex® vascular graft to gore-tex® stretch vascular graft in the event description.D.1.Brand name - corrected gore-tex® vascular graft to gore-tex® stretch vascular graft as the brand name.H.6.Results code 1: the device fragments were returned to w.L.Gore & associates for investigation.Submitted in formalin were two gore-tex® stretch vascular graft fragments.Device fragments had been transected prior to arrival at w.L.Gore and associates.The lumens of both devices were widely patent.Both fragments were generally devoid of tissue except scant scattered plaques of friable dark red/brown material and had multiple evenly spaced serration marks visible on the abluminal surface.Each fragment presented with a smooth cut edge which had full thickness material holes present circumferentially and a blue suture fragment present in one of the holes; consistent with an anastomotic end.Both fragments also had a rough/jagged cut end with a notch of material cut from the device.When aligned, the notches in material form a roughly cut hole measuring approximately 5mm in diameter.Histopathological analysis was not performed due to the paucity of adherent tissue.The device fragments were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices were examined for material disruptions with the aid of a stereomicroscope.Anastomotic sites are evident on both device fragments.The opposite poles consisted of jagged cut ends which align to create the whole implanted graft.At approximately the center of the device there was a roughly cut hole (created when the notches are aligned) which would be consistent with the re-fenestration procedure.Material disruptions from surgical instruments (e.G., forceps, clamps) were present throughout the fragments.Sem imaging revealed no evidence of luminal surface material aberrations aside from the serration marks.The gore-tex® stretch vascular graft instructions for use note that thrombosis is a possible complication with the use of any vascular prosthesis.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8203814
• MDR Text Key: 131644369
• Report Number: 2017233-2018-00802
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Catalogue Number: SGS-183L
• Device Lot Number: 18364506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR