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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER
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AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Model Number 9-ASD-032
Device Problems Material Deformation (2976); Material Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  malfunction  
Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
 
Event Description
On (b)(6) 2019, a 32mm amplatzer septal occluder was selected for implant using a 45/80mm 12f amplatzer torqvue delivery system (lot number: unknown).During the procedure, the device deformed and loose threads were observed protruding from the device after massaging.The device was exchanged for a 34mm amplatzer septal occluder (lot number: 6545113) as the site had no other 32mm amplatzer septal occluders.The second device was implanted without issue and no patient consequences were reported.
 
Manufacturer Narrative
An event of device deformation and polyester sewing thread protruding from the device was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis; however, three photos were received for analysis.Based solely on the aforementioned photos, the device did appear to deformed in a "cobra" conformation.The device also appeared to have a protruding sewing knot on the proximal disc.The sewing knots seen above the nitinol wires are considered a normal and acceptable characteristic of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
On (b)(6) 2019, a 32mm amplatzer septal occluder was selected for implant using a 45/80mm 12f amplatzer torqvue delivery system (lot number: unknown).During the procedure, the device deformed and loose threads were observed protruding from the device after massaging.The device was exchanged for a 34mm amplatzer septal occluder (lot number: 6545113) as the site had no other 32mm amplatzer septal occluders.The second device was implanted without issue and no patient consequences were reported.
 
Manufacturer Narrative
An event of a protruding polyester thread and device deformation was reported.The knots met dimensional specifications and the device met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The sewing knots that are seen above the nitinol wires are considered a normal and acceptable characteristic of the occluder.
 
Event Description
On (b)(6) 2019, a 32mm amplatzer septal occluder was selected for implant using a 45/80mm 12f amplatzer torqvue delivery system (lot number: unknown).During the procedure, the device deformed and loose threads were observed protruding from the device after massaging.The device was exchanged for a 34mm amplatzer septal occluder (lot number: 6545113) as the site had no other 32mm amplatzer septal occluders.The second device was implanted without issue and no patient consequences were reported.
 
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Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8827367
MDR Text Key157324486
Report Number2135147-2019-00196
Device Sequence Number1
Product Code MLV
UDI-Device Identifier00811806010236
UDI-Public00811806010236
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model Number9-ASD-032
Device Catalogue Number9-ASD-032
Device Lot Number6391956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2018
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 Age38 YR
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