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

Catalog Number	9-PFO-025
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, an amplatzer pfo occluder was noted to have embolized six weeks after implant and the patient had an arrhythmia.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, "a very rare and unusual complication after a percutaneous patent foramen ovale closure" was reviewed.The article presented a case study of a 47-year-old female who presented with an atrial septal aneurysm and patent foramen ovale (pfo).It was reported that on an unknown date, a 25mm amplatzer pfo occluder was implanted to occlude a pfo without issue and reassuring tug test.Six weeks post procedure, the patient presented with palpitations and subsequent imaging revealed the device had embolized into the descending aorta.A decision was made to explant the device via transcatheter snare.The article concluded that this case demonstrated that percutaneous retrieval of an embolized pfo occluder, although challenging, is feasible and might be a viable alternative to a riskier conventional surgical approach, with the double snare technique and large sheath usage potentially improving success rates and reducing re-embolization risks.[the primary and corresponding author was claudiu ungureanu, cardiovascular jolimont hospital, rue ferrer, 159, 7100 la louvière, belgium; and 2cardiovascular department, clinique saint joseph, vivalia, arlon, belgium, with corresponding email: claudiu.Ungureanu@jolimont.Be].

• Brand Name: AMPLATZER PFO OCCLUDER
• 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: 18369649
• Report Number: 2135147-2023-05636
• Device Sequence Number: 7580410
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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-PFO-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female