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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER
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ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Model Number 9-ASD-014
Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
On (b)(6) 2021 a 14 mm amplatzer septal occluder was chosen for implant procedure.During a follow-up visit in late (b)(6), it was reported that there was shunting across the atrial septum and there was concern that the device may have migrated.On (b)(6) 2021 the patient returned to the cath-lab.During this procedure, it had been determined the device had migrated into the aorta.The device was removed.The patient will have the asd surgically repaired on a later date.
 
Manufacturer Narrative
Additional information: g3, g6, h2, h6, h10 an event of device embolization was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key11698183
MDR Text Key246428385
Report Number2135147-2021-00118
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number9-ASD-014
Device Catalogue Number9-ASD-014
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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