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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
Catalog Number 9-ASD-022
Device Problem Difficult to Fold, Unfold or Collapse (1254)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2024, a 22mm amplatzer septal occluder was chosen for an atrial septal defect (asd) procedure using a 9f amplatzer trevisio intravascular delivery system.The defect was measured as 19mm by transesophageal echocardiography (tee).The sizing of the device was measured by angiography and tee.During procedure, the device was assembled and observed a cobra deformation when it was deployed outside the jacket.The device was removed from the patient, immersed in warm solution for two minutes, then massaged and reassembled.The device was deployed out of the shirt and once again takes effect, the device and the patient's releaser are removed.The device was mounted once again, the release test was performed outside the patient and the device takes effect.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 24mm amplatzer septal occluder was chosen and device was positioned.But the device was removed from the patient with lax edges and patient was refereed to cardiothoracic surgery.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
 
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.The cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that on (b)(6) 2024, a 22mm amplatzer septal occluder was chosen for an atrial septal defect (asd) procedure using a 9f amplatzer trevisio intravascular delivery system.The defect was measured as 19mm by transesophageal echocardiography (tee).The sizing of the device was measured by angiography and tee.During procedure, the device was assembled and observed a cobra deformation when it was deployed outside the jacket.The device was removed from the patient, immersed in warm solution for two minutes, then massaged and reassembled.The device was deployed out of the shirt and once again takes effect, the device and the patient's releaser are removed.The device was mounted once again, the release test was performed outside the patient and the device takes effect.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 24mm amplatzer septal occluder was chosen and device was positioned.But the device was removed from the patient with lax edges and patient was refereed to cardiothoracic surgery.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
 
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Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL REG# 2135147
5050 nathan ln n
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key18886125
MDR Text Key337566182
Report Number2135147-2024-01079
Device Sequence Number1
Product Code MLV
UDI-Device Identifier00811806010182
UDI-Public00811806010182
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9-ASD-022
Device Lot Number8379025
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2022
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 Age10 YR
Patient SexMale
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