MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Hepatic or Biliary Problem (4493)

Event Date 11/01/2002

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, a further investigation on the device cannot be performed.For further evaluation the author was asked, if more details such as lot-no., date of event, implant-date, as well as patient details and possible root causes are available.Date of event was determined as november 1, 2002 as mentioned in the article.As patient age 84 years was determined and as gender male as mentioned in the article.

Event Description

The following literature was reviewed: ¿non-iatrogenic common bile duct injury repair by gore-tex vascular graft: a case report¿ published by alessandro besozzi et al.In the chirurgia italiana, march 1, 2004 ¿ vol.56 no.2 pp 261-264.The authors report their experience with non-iatrogenic common hepatic duct injuries that, due to technical difficulties, were repaired by means of a pioneering technique, namely the gore-tex® vascular graft.It was reported that an 84-year-old male patient in whom due to an infundibular gallbladder stone lying in the common hepatic duct (chd), when the cholecystectomy was performed, a wide gap was detected in the chd.A gore-tex® vascular graft was applied.The postoperative clinical outcome was unremarkable and a sudden improvement in lung function test parameters was noticed.Further cholangiographies were performed and a progressive improvement was noticed, despite the fact that an endoscopic retrograde cholangio-pancreatography (ercp) performed 3 months after the operation showed the prosthesis partially collapsed and moderate dilatation of the intrahepatic bile ducts.

Manufacturer Narrative

The case was internally reviewed by the product specialist, the office of medical affairs representative, the regulatory representative, and qa representative.The clinical description of the event and details from the literature article were evaluated.It was decided the information is not a complaint against the gore device as the article describes no harm to the patient, the reported ¿partially collapsed¿ prothesis was an observation noted following endoscopic retrograde cholangiopancreatography (ercp) at 3 months with no indication of obstruction or blockage, and no failure of the device to perform as intended, therefore this information does not meet the criteria for a reportable serious injury.The report will be retracted.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12313446
• MDR Text Key: 266222679
• Report Number: 2017233-2021-02237
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• 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 Age: 84 YR
• Patient Sex: Male