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

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Due to an unknown lot/serial number and no device return, an investigation could not be performed.

Event Description

The literature article: ¿(moraxella catarrhalis bacteremia associated with lower extremity bypass graft infection)¿ published by (travis sullivan) was reviewed.The article was published online or accepted on (june-1-2019).The use of (gore® propaten® vascular graft) was evaluated for ( redo right common femoral to below knee popliteal bypass).The article was a single case study of a (b)(6) year-old caucasian man right common femoral to below knee popliteal bypass with gore® propaten® vascular graft.Article states that patient presented two weeks post operatively with right lower extremity edema, surgical incision drainage, and fever.Cultures grew gram-negative rods and was later suspected to be morazella catarrhalis.The patient was taken to the operating room and the gore device was explanted.After discussion with the product specialist this article is a reportable event.

Manufacturer Narrative

The literature article: ¿(moraxella catarrhalis bacteremia associated with lower extremity bypass graft infection)¿ published by (travis sullivan) was reviewed.The article was published online or accepted on ((b)(6) 2019).The use of (gore® propaten® vascular graft) was evaluated for ( redo right common femoral to below knee popliteal bypass).The article was a single case study of a 64-year-old caucasian man right common femoral to below knee popliteal bypass with gore® propaten® vascular graft.Article states that patient presented two weeks post operatively with right lower extremity edema, surgical incision drainage, and fever.Cultures grew gram-negative rods and was later suspected to be morazella catarrhalis.The patient was taken to the operating room and the gore device was explanted.

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE PROPATEN 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
• MDR Report Key: 12246771
• MDR Text Key: 264106065
• Report Number: 2017233-2021-02203
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR