W. L. GORE & ASSOCIATES, INC. GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|