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

Model Number 9-ASD-MF-025

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer report number: 2135147-2021-00566.On (b)(6) 2021, a 25mm amplatzer cribriform occluder (lot number: 8037019) was selected for implant.During positioning, the left disc deployed deformed and was removed from the patient.The device was tested outside of the patient and continued to deploy deformed.Another 25mm amplatzer cribriform occluder (lot number: 8044841) was selected.During positioning, the right disc deployed deformed and was removed from the patient.A 25 pfo occluder (lot number: 8098555) was used to complete the procedure.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.No patient consequences were reported.No additional information was provided.

Manufacturer Narrative

An event of device deformity was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

An event of device deformation was reported.The investigation confirmed the device met functional specifications when analyzed at abbott 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 event could not be conclusively determined.

• Brand Name: AMPLATZER CRIBRIFORM 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: 13023530
• MDR Text Key: 284522176
• Report Number: 2135147-2021-00567
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: 00811806010298
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 8037019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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