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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® CARDIOFORM SEPTAL OCCLUDER; OCCLUDER, TRANSCATHETER SEPTAL
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W.L. GORE & ASSOCIATES GORE® CARDIOFORM SEPTAL OCCLUDER; OCCLUDER, TRANSCATHETER SEPTAL Back to Search Results
Device Problem Complete Blockage (1094)
Patient Problem Pulmonary Embolism (1498)
Event Date 06/17/2017
Event Type  Injury  
Event Description
It was reported to gore that a gore® cardioform septal occluder was recently implanted to close a patent foramen ovale.It was reported the patient developed a pulmonary embolism and echocardiogram performed during the weekend of (b)(6) 2017 showed a clot on the right atrial disc of the device.The patient is being treated with coumadin and is reported to be doing well.
 
Manufacturer Narrative
Conclusion codes added.Attempts were made to obtain additional patient, event, and device information but no response was received.
 
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Brand Name
GORE® CARDIOFORM SEPTAL OCCLUDER
Type of Device
OCCLUDER, TRANSCATHETER SEPTAL
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
KENDRICK PEAK MPD B/P
4250 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
kathy titus
9285263030
MDR Report Key6714157
MDR Text Key80055466
Report Number2017233-2017-00350
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup
Report Date 07/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Other; Required Intervention;
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