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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Thrombosis (2100); Ulcer (2274)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Udi # unknown.

Event Description

Within the article ¿spontaneous migration of thrombosed synthetic vascular graft to the duodenum after living-donor liver transplantation: a case-report¿, published by ahmed mohamed sultan et al, within the international journal of surgery case reports, published on march 15, 2018, the circulated results indicated the following: a (b)(6) male patient with end stage liver disease due to chronic hepatitis c virus infection underwent living donor liver transplantation utilizing a right hemi-liver graft from his son.Right hepatic vein reconstruction was done by end-to-side anastomosis between donor right hepatic vein and inferior vena cava using continuous 4/0 polypropylene sutures with venoplasty.Drainage of segment v vein was done to side of inferior vena cava using an externally supported polytetra-fluoroethylene (ptfe) synthetic vascular graft (gore-tex 6 mm in diameter) by 4/0 polypropylene sutures.Reconstruction of the portal vein was done by end-to-end anastomosis between donor right portal vein and recipient main portal vein using continuous 5/0 polypropylene sutures.Reconstruction of the hepatic artery was done by end-to-end anastomosis between donor right hepatic artery and recipient right hepatic artery using interrupted 8/0 polypropylene sutures.Doppler ultrasound (us) examination was done after completion of vascular anastomoses and at the end of operation which confirmed patency of all vascular anastomoses.Doppler us was performed daily in the first postoperative week to evaluate patency of vascular anastomoses, and twice weekly afterwards till patient discharge.The patient had smooth post-operative course, and was discharged without complications.Follow up doppler us was done regularly to confirm patency of vascular anastomoses.No vascular abnormalities were detected apart from thrombosis of segment v vein, which was detected in the fourth postoperative month.During an endoscopic retrograde cholangio-pancreatography (ercp) set that was done two and half years after transplantation, the thrombosed synthetic vascular graft was seen eroding into the first part of the duodenum.The procedure was completed and balloon dilatation of the anastomotic stricture and re-stenting was done.The patient was generally stable and the decision was to follow up the condition of the eroding synthetic vascular graft.A computed tomography was done 1 week later and showed disappearance of the synthetic vascular graft from the abdomen.Follow up endoscopy afterwards revealed a small ulcer in the first part of the duodenum at the site of the migrated synthetic vascular graft with no other abnormalities.In this report, we describe a rare case of spontaneous migration of thrombosed synthetic vascular graft after living donor liver transplantation (ldlt).The patient did not have any emergency situation like intra-abdominal sepsis or bleeding or intestinal obstruction, and the decision to observe and follow up the patient was wise enough to avoid unnecessary surgical exploration.Spontaneous expulsion of the migrated vascular graft from the digestive tract occurred without any complications.The real mechanism for the migration of the thrombosed graft is not fully understood.We think that repeated endoscopic retrograde cholangio-pancreatography (ercp) sets for the management of anastomotic biliary stricture and repeated stent placements may play the major role in synthetic graft thrombosis and subsequent migration into the first part of the duodenum.

Manufacturer Narrative

Multiple attempts have been made from the product surveillance coordinator to the author over an extended period of time in order to get additional information.As no information related to this complaint has been or will be provided by the author, this event will be closed with the information received.(b)(4).

• Brand Name: GORE-TEX® 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7457418
• MDR Text Key: 106391834
• Report Number: 2017233-2018-00236
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2018
• 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): Other
• Patient Age: 59 YR