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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM ASD OCCLUDER; TRANSCATHETER, SEPTAL OCCLUDER
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W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM ASD OCCLUDER; TRANSCATHETER, SEPTAL OCCLUDER Back to Search Results
Catalog Number ASD44E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Thrombus (2101); Transient Ischemic Attack (2109)
Event Date 11/18/2020
Event Type  Injury  
Manufacturer Narrative
The gore® cardioform asd occluder instructions for use states: potential clinical and device adverse events associated with the use of the occluder may include, but are not limited to: device thrombosis or thromboembolic event resulting in clinical sequelae, fever.
 
Event Description
It was reported to gore a 44mm gore® cardioform asd occluder was implanted on (b)(6) 2020 to treat an atrial septal defect with almost no aortic rim and balloon sized at 20x22mm.The occluder was implanted without any problem.It was reported the patient developed a fever 36 hours after the uneventful closure.A large thrombus formation on the right atrial side of the device was subsequently confirmed by trans-oesophageal echocardiogram (toe) on (b)(6) 2020.The patient is on antibiotics and anticoagulation with heparin after one course of rtpa.Follow-up toe is scheduled for (b)(6) 2020.It was reported on (b)(6) 2020 that the patient feels well, has no fever, and the thrombus formation is gone.For the next 6 months the patient will receive anticoagulants.
 
Event Description
It was reported to gore a 44mm gore® cardioform asd occluder was implanted on (b)(6) 2020 to treat an atrial septal defect with almost no aortic rim and balloon sized at 20x22mm.The occluder was implanted without any problem.It was reported the patient developed a fever 36 hours after the uneventful closure.A large thrombus formation on the right atrial side of the device was subsequently confirmed by trans-oesophageal echocardiogram (toe) on (b)(6) 2020.The patient is on antibiotics and anticoagulation with heparin after one course of rtpa.Follow-up toe is scheduled for (b)(6) 2020.It was reported on (b)(6) 2020 that the patient feels well, has no fever, and the thrombus formation is gone.For the next 6 months the patient will receive anticoagulants.Additional information was received on (b)(6) 2021 from the implanting physician who reported that in (b)(6) 2020 the patient again developed fever and transient ischemic attack (tia).The patient contacted the neurology department of a different hospital and while there the tia was not clinically evident any more.The patient was then referred to medizinische hochschule hannover, department of adult cardiology, where a transesophageal echocardiography (tee) was performed.This tee showed thrombus on the right side although the patient was taking marcumar at this time.A decision was made to explant the occluder surgically on (b)(6) 2021.The implanting physician was not involved in this decision.The explanted device was sent to a lab at the university hospital in göttingen for investigation.The initial results of the investigation of the explanted device showed granulocytes in the thrombotic material and the implanting physician is awaiting the final results.
 
Manufacturer Narrative
B3: updated event description d6: added explant date h6: added clinical code, added impact code, updated conclusion code.
 
Manufacturer Narrative
H6: updated investigation conclusion code.H6 code 22: the gore® cardioform asd occluder instructions for use states: potential clinical and device adverse events associated with the use of the occluder may include, but are not limited to: stroke or tia.
 
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Brand Name
GORE CARDIOFORM ASD OCCLUDER
Type of Device
TRANSCATHETER, SEPTAL OCCLUDER
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10950622
MDR Text Key219912309
Report Number2017233-2020-01501
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 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/16/2022
Device Catalogue NumberASD44E
Was Device Available for Evaluation? No
Date Manufacturer Received11/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age30 YR
Patient Weight56
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