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 12/15/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, a 25mm amplatzer cribriform occluder was selected for implant.During positioning, the left disc deployed with a bulbous shape and was retracted and removed from the patient.The device was tested outside the patient and the deformation persisted.A new 25mm amplatzer cribriform occluder was successfully implanted.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

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

Manufacturer Narrative

The reported event of device deformity could not be confirmed.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.

• 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: 13192371
• MDR Text Key: 284521930
• Report Number: 2135147-2021-00577
• 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
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 7451614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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