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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER, SEPTAL OCCLUDER
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W.L. GORE & ASSOCIATES GORE® CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER, SEPTAL OCCLUDER Back to Search Results
Catalog Number GSX0025A
Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The review of the manufacturing and sterilization records verified that this lot met all pre-release specifications.Patient weight requested but not provided.The imaging evaluation revealed the device appears to be in a satisfactory position, however without additional imaging this cannot be confirmed.There appears to be a foreign object attached to the right atrial disc of the implanted device that protrudes into the right atrium.The object appears to be consistent with a thrombus, however without histology testing this cannot be confirmed.The device remains in place.
 
Event Description
It was reported to gore a 25 mm gore® cardioform septal occluder was implanted on (b)(6) 2018 to close a patent foramen ovale.It was reported the patient developed a vegetation on the right side of the gore® cardioform septal occluder.Also noted was bacteremia, endocarditis, and vegetation in the aortic valve.The patient is being treated with potent antibiotics; however, the outlook is poor.As the vegetation was noted on the occluder as well as the aortic valve, the decision was made to not attempt removal of the device by snare and leave it implanted.It was also reported the patient had a dental procedure after device implant and was not given antibiotics.The physicians theorize that her immunocompromised system, matched with the dental procedure, caused the bacteremia issue.It was also reported that the patient is waiting for a liver transplant.
 
Manufacturer Narrative
Additional information: weight.Describe event or problem event description (updated information) other relevant history, including preexisting medical conditions(e.G., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal sysfunction, etc.).
 
Event Description
It was reported to gore a 25mm gore® cardioform septal occluder was implanted on (b)(6)2018 to close a patent foramen ovale.It was reported the patient developed a vegetation on the right side of the gore® cardioform septal occluder.Also noted was bacteremia, endocarditis, and vegetation in the aortic valve.The device was successfully explanted on (b)(6)2018.The patient is to be treated with six weeks of antibiotics, following which she will be re-evaluated for defect closure.
 
Manufacturer Narrative
Event: additional information.
 
Event Description
It was reported to gore a 25mm gore® cardioform septal occluder was implanted on (b)(6), 2018 to close a patent foramen ovale.It was reported the patient developed a vegetation on the right side of the gore® cardioform septal occluder.Also noted was bacteremia, endocarditis, and vegetation in the aortic valve.The device was successfully explanted on (b)(6), 2018.The patient was treated with six weeks of antibiotics, following which she was re-evaluated for defect closure.It was reported the patient received another gore® cardioform septal occluder implanted (b)(6) 2018.The patient was reported to be doing well following the procedure.
 
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Brand Name
GORE® CARDIOFORM SEPTAL OCCLUDER
Type of Device
TRANSCATHETER, SEPTAL OCCLUDER
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key7625502
MDR Text Key111892728
Report Number2017233-2018-00330
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
PMA/PMN Number
P050006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/26/2019
Device Catalogue NumberGSX0025A
Device Lot Number17380256
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age28 YR
Patient Weight70
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