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

Model Number	MF SEPTAL OCCLUDER CRIBRIFORM
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 35mm amplatzer cribriform occluder was selected for procedure.It was noted during procedure that the right atrial disc of the occluder exhibited a deformation.In addition, the occluder was difficult to screw on and could not be deployed.The decision was made to remove and replace the 35mm amplatzer cribriform occlude with a non-abbott device to complete the procedure.There were no adverse patient consequences reported.The patient was stable at the time of report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity and difficulty in the occluder attaching to the delivery cable could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2022, a 35mm amplatzer cribriform occluder was selected for procedure.It was noted during procedure that the right atrial disc of the occluder exhibited a deformation.In addition, the occluder was difficult to screw on and could not be deployed.The decision was made to remove and replace the 35mm amplatzer cribriform occlude with a non-abbott device to complete the procedure.There were no adverse patient consequences reported.The patient was stable at the time of report.Subsequent to the previously filed report, additional information was received and a correction needs to be made has the deformed right atrial disk of the 35mm amplatzer cribriform occluder was noted prior to procedure during device preparation.There was no patient contact made with the deformed occluder.It was also noted that there was difficulty screwing the delivery cable onto the occluder during the device preparation.It is unknown how the occluder was sized.There was no kink or angulation noted in the delivery system.The replacement device that was implanted was a 36mm non-abbott device.The delivery system used was an unknown abbott delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was stable at the time of report.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Common Device Name: 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 Key: 15729160
• Report Number: 2135147-2022-01924
• Device Sequence Number: 2872528
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: MF SEPTAL OCCLUDER CRIBRIFORM
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 7684602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/22/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown