MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-032

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturer report number: 2135147-2021-00334.It was reported that on (b)(6) 2021, a 28 mm amplatzer septal occluder was chosen for implant.During procedure, the device deployed as a cobra head deformation 2-3 times while inside the patient.The device was replaced with a 32 mm amplatzer septal occluder, but after deploying the left atrial disc, the right atrial disc was unable to open.The decision was made to send the patient to open heart surgery to retrieve the second device and to close the patient's atrial septal defect (asd).In surgery, the second device was successfully retrieved, and the patient's asd was surgically closed.There was a clinically significant delay in procedure of more than 1 hour due to this event.The patient remained hemodynamically stable throughout the procedure, and the patient did not experience any other adverse event.No additional information was provided.

Event Description

Related manufacturer report number: 2135147-2021-00334.Additional information was received, that indicates that the 32 mm amplatzer septal occluder embolized, after being released from the delivery cable.And attempts to snare the device were unsuccessful.The patient was sent to emergency open heart surgery to retrieve the second device.And to close the patient's atrial septal defect (asd), which was successfully completed.

Manufacturer Narrative

An event of device embolization was reported.The investigation confirmed the device met functional and dimensional 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.The cause of the reported incident could not be conclusively determined.Please note, per the amplatzer septal occluder instructions for use, artmt600034451 rev.A "warnings: do not release the device from the delivery cable if the device does not conform to its original configuration or if the device position is unstable or if the device interferes with any adjacent cardiac structure, such as superior vena cava (svc), pulmonary vein (pv), mitral valve (mv), coronary sinus (cs) or aorta (ao).Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace with a new device.".

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12334324
• MDR Text Key: 267040497
• Report Number: 2135147-2021-00333
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010236
• UDI-Public: 00811806010236
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 9-ASD-032
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: 6744046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female