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

Catalog Number RGTWR-107070L

Device Problem Material Puncture/Hole (1504)

Patient Problem Blood Loss (2597)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.As the devices were not returned, no evaluation of the devices could be performed.

Event Description

On (b)(6) 2019, the patient was implanted with a gore-tex® vascular graft (rgtwr-107070l) to treat a femoral artery aneurysm.It was reported the physician cut the rgtwr-107070l into approximately 5 cm x 2 pieces.Anastomoses were performed in the order of: distal side, proximal side, and two devices.The suture reportedly used was a cv5.Bleeding from all three anastomotic portions was reportedly identified and did not stop.It was reported that the physician sutured the devices along with the removable ring (without removing the removable ring).Reportedly as the bleeding did not stop, the physician removed the pieced of the device, and cut rest of rgtwr-107070l into approximately a 10 cm x 1 piece.It was reported anastomosis was again performed.The suture used was reportedly a 5-0 prolene.It was reported the removable ring was removed only at the anastomotic portion of the device.Bleeding was again severe, however, the physician reportedly could stop the bleeding.The total amount of blood loss was 2,500 ml.It was reported a transfusion was performed.The patient tolerated the procedure.The physician stated that he thought that poor hemostasis was due to the device failure.It was reported during the first anastomosis, it was reported that the physician sutured the devices along with the removable ring (without removing the removable ring).It was reportedly suspected there is possibility that the anastomosis was not successful as a result.It was reported prior to implanting the rgtwr-107070l, a stent was implanted for stenosis of the distal artery.Reportedly it is suspected there is a possibility that heparin dilution was performed again without measuring act (activated clotting time).It was reported that might be one of cause that have contributed to poor hemostasis.It was reported that thrombus could not form after the hemostasis for approximately 2 hours.

Manufacturer Narrative

Corrected g5 combination product - no.

• Brand Name: GORE-TEX VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9500110
• MDR Text Key: 183087307
• Report Number: 2017233-2019-01260
• 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
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2021
• Device Catalogue Number: RGTWR-107070L
• Device Lot Number: 15374142
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention