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

Catalog Number	9-ASD-MF-035
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 35mm amplatzer cribriform occluder was implanted.The sizing of the device was determined via echo.Stability check was performed and no leak was observed.There were no reported difficulties during implant.One hour post-implant, the occluder completely dislodged from the implant site and embolized to the pulmonary artery.It is suspected that intra-cardiac imaging did not support fully ensuring the occluder was fully implanted.The patient did not experience a rhythm change during procedure, but did experience arrythmia 1.5 hours post-implant.The occluder was snared percutaneously with an 18f snare and removed.A new 30mm amplatzer pfo occluder was successfully implanted.The patient was reported to be in stable condition.Of note, a 25mm amplatzer cribriform occluder was mis-sized prior to the 35mm cribriform.There are no allegations of malfunction with the 25mm cribriform.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device migration) and explant was reported.The device was returned to abbott for investigation and the device met dimensional specifications when analyzed.It was suspected that intra-cardiac imaging did not support fully ensuring the occluder was fully implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The echo imaging provided showed the implant in position and then later no implant present.It appears that the implant was in a reasonable position prior to release.Based on the available information, the cause of the reported event appears to be related to procedural condition and patient conditions.The reported unexpected medical intervention was a result of case-specific circumstances as a device was snared and removed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 20463383
• Report Number: 2135147-2024-05102
• Device Sequence Number: 15402035
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: (01)00811806010311(17)270228(10)8411834
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 8411834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG