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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

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W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Model Number GSX0030A
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem Pericardial Effusion (3271)
Event Date 05/08/2021
Event Type  Injury  
Manufacturer Narrative
The gore® cardioform septal occluder instructions for use list significant pleural or pericardial effusion requiring drainage as a potential device- or procedure-related adverse event.
 
Event Description
It was reported the physician selected a 30mm gore® cardioform septal occluder to treat a patent foramen ovale on (b)(6) 2021.During deployment, the right atrial disc appeared to deploy in the tunnel.The device was recaptured, redeployed, and implanted with good results.The afternoon following the procedure, a pericardial effusion was noted.Pericardiocentesis was performed and no further intervention was required.Following negative surface echocardiography findings, the patient was discharged (b)(6) 2021.
 
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Brand Name
GORE CARDIOFORM SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
KENDRICK PEAK MPD B/P
4250 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
marci stewart
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11912688
MDR Text Key253499959
Report Number2017233-2021-02039
Device Sequence Number1
Product Code MLV
UDI-Device Identifier00733132631032
UDI-Public00733132631032
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/22/2023
Device Model NumberGSX0030A
Device Catalogue NumberGSX0030A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/08/2021
Date Device Manufactured12/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight65
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