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

Catalog Number SRRT05030040L

Device Problem Fluid/Blood Leak (1250)

Patient Problem Discharge (2225)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Histology evaluation of returned specimen is currently in progress.

Event Description

The following was reported to gore: on (b)(6) 2018, a patient presented with an occluded ivc filter, heavily thrombosed inferior vena cava and iliac veins.In preparation for treatment, a 20mm ringed gore-tex® vascular graft was sewn into two 10mm ringed gore-tex® vascular grafts to create a bifurcation.The physician then attached the 20mm vascular graft in an end-to-end fashion to the ivc.The newly created bifurcated 10mm vascular grafts were then tunneled and attached to the common femoral veins in an end-to-side fashion.Next, a 5mm ringed vascular graft was cut in half to create the arteriorvenous (av) graft between the common femoral artery and the 10mm ringed gore-tex® vascular graft that was now bypassing the iliac vein system.One half of the 5mm av graft segment in the patient¿s left leg was event free.The other half of the 5mm av graft segment in the patient¿s right leg developed a clear weeping fluid.As reported, the vascular graft was clamped just below the anastomosis and ultrafiltration was seen throughout the whole segment of the graft.A drain and prevent-a-wound vac was placed to assist with drainage.On (b)(6) the cut segment of the 5mm graft in the right leg was explanted and a new gore-tex® vascular graft was implanted.

Manufacturer Narrative

The engineering evaluation state the intra-operative photos received from physician were reviewed.The photos show clear fluid on the abluminal surface of the device, but no material disruptions could be identified from the photos.An evaluation of the returned device showed both ends of the graft segment were cut at approximately a 45° angle, and suture was present on both cut ends.The segment measured approximately 12cm long.Rings were deformed along the entire segment, with the apices of the compressed rings in alignment with the creases near the anastomoses.The exterior of the graft presented with varying degrees of tissue attachment across the abluminal surface.All rings and longitudinal film appeared in-tact, with no visually apparent perforations or damage to the abluminal surface.A segment of the graft was returned; histological evaluation is currently in progress.

Event Description

On august 31, additional information was received.The vascular graft was wiped and suctioned, followed by application of fibrin glue in attempt to stop the ultrafiltration.

Manufacturer Narrative

Code 213: explant evaluation task was performed: the fragment submitted unfixed was a gore-tex® vascular graft ¿ thin-walled removable ringed fragment (vgf).The device fragment had been transected prior to arrival at w.L.Gore and associates.The vgf was u shaped with elliptical transected (beveled) and compressed ends (poles).Both poles had fragments of blue suture and transmural holes along the bevel cut edges.The pattern of the transected poles and the presence of suture within holes located at the poles was consistent with surgically created anastomotic sites.Both poles had lacerations/ tears present in graft material adjacent to transected edge.Noted at both poles was also the presence of evenly spaced serrations marks.All rings present on the fragment were intact.The lumen at the poles of vgf contained a small amount of friable brown tan material.Luminal patency is indeterminable due to the shape and compression of the returned specimen.The ablumen was multifocally covered by minimal amount of tan brown material, the apex region of the curved vgf was generally devoid of tissue.Histopathological examination of two tissue specimens located on the albumen of vgf were collected and submitted for histopathological analysis.The tissue examined is consistent with acute fibrillar proteinaceous coagulum.The material is consistent with serum filtration through the graft admixed with frank blood (surgical origin, presumptive).Also present were ribbons of a hyaline amorphous protein which is most consistent with surgically applied fibrin glue or similar tissue adhesive.There is no evidence of inflammation.The etiology of the seroma is undetermined from the histologic examination.The fragment was subjected to an enzymatic digestion process to remove biologic debris.Following digestion the fragment was examined for material disruptions with the aid of a stereomicroscope.Disruptions identified were not associated with handling or manufacturing process at wl gore and associates.The disruptions are consistent with surgical procedures (i.E., implant and/or explant procedure).There are no material findings to explain the reported weeping of the graft.The radial film layer is visible and present along the entire fragment except approximately 1-2mm edge of pole 2 along the toe of the bevel end (anastomotic site).All rings present on the fragment are intact.

• 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: 7492687
• MDR Text Key: 107560544
• Report Number: 2017233-2018-00259
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K933943
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Catalogue Number: SRRT05030040L
• Device Lot Number: 16618549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TUNNELER
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 73