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

Catalog Number SRGTWR-054030L

Device Problem Complete Blockage (1094)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Unspecified Infection (1930)

Event Date 05/30/2017

Event Type  Death  

Manufacturer Narrative

The patient expired in (b)(6) 2017, but an exact date is unknown.Therefore, (b)(6) 2017 is determined to be the date of death.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore-tex® stretch vascular graft instructions for use (ifu), complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to infection and thrombosis.(b)(4).

Event Description

On (b)(6) 2017, the patient underwent norwood procedure to treat hypoplastic left heart syndrome (hlhs).During this procedure, a gore-tex® stretch vascular graft (srgtwr-054030l/(b)(4)) was used as a shunt between the right ventricle and the pulmonary artery.Also a clip was put on the shunt to control the amount of blood flow.On and around (b)(6) 2017 (21 days post initial procedure), the patient suffered from blood-stream infection.It was reported that catheters which had been put in the patient prior to the initial procedure could have caused or contributed to the blood-stream infection.On the same day, the patient received antimicrobial therapy.Approximately two weeks since the antimicrobial therapy had started, blood culture exam revealed that the patient was negative against infection.In (b)(6) 2017 (two months post initial procedure), the patient suffered from the blood-stream infection again.It was reported that a cause of infection was the same as the previous infection.The patient received the antimicrobial therapy.Also, computed tomography (ct) and echography were performed, revealing that the gore-tex® stretch vascular graft had not been thrombosed.In (b)(6) 2017 (three months post initial procedure), the patient was discharged.Later in follow-up studies, the patient was doing fine.In (b)(6) 2017 (four months post initial procedure), the patient got in cardio-pulmonary arrest and emergently admitted to the hospital.Resuscitation was not successful and the patient expired.It was reported that autopsy of the patient¿s heart was performed, confirming that a large amount of bacteria was present on pores of eptfe graft.Also, there was present a mass of bacteria inside the graft where it was clipped and narrowed, which could have caused thrombosis of the graft.Additionally, it was reported that the same bacteria was also found in the graft anastomosis site on the right ventricle.

Manufacturer Narrative

The review of the sterilization paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE-TEX® STRETCH 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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7008511
• MDR Text Key: 91287780
• Report Number: 2017233-2017-00582
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K933943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2021
• Device Catalogue Number: SRGTWR-054030L
• Device Lot Number: 14987770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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): Death
• Patient Weight: 4