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

Catalog Number	9-PFO-025
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Rash (2033)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported through a article review a 41-year-old male patient with prior episodes of decompression illness (dci), prior hyperbaric oxygen therapy, smoking history, dyslipidemia, and a patent foramen ovale (pfo).It was reported a 25mm amplatzer pfo was implanted.During a follow up transesophageal echocardiography (tee) examination using saline bubbles showed the pfo was well seated in the interatrial septum without a peridevice thrombus.However, it was also noted that >20 saline bubbles still crossed the remnant pfo channel during the valsalva maneuver.The patient was advised to refrain from diving but was non-compliant.Later on, the patient experienced headache, painful sensation in the hands and feet, and skin rash and pruritus in both feet due to recurrent decompression illness.The patient underwent hyperbaric oxygen chamber therapy.The article concluded that this case indicates that the risk of dci may remain even after pfo closure.The incomplete closure of pfo due to delayed endothelialization around the device, decompression sickness, and arterial gas embolism through the pulmonary circulation should be considered.Divers should be educated on maintaining a conservative diving protocol to decrease nitrogen gas load, and avoiding some measures to promote arterial embolization of nitrogen bubbles by increasing rap during ascent.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Based on the available information, the root cause of the reported event could not be conclusively determined.
Event or Problem Description
The article, "recurrent decompression illness even after the closure of patent foramen ovale in a diver", was reviewed.The article presented a case study of a 41-year-old male patient with prior episodes of decompression illness (dci), prior hyperbaric oxygen therapy, smoking history, dyslipidemia, and a patent foramen ovale (pfo).It was reported that on an unknown date, a 25mm amplatzer pfo was implanted.It was then reported six months post-procedure, during a follow up transesophageal echocardiography (tee) examination using saline bubbles showed the pfo was well seated in the interatrial septum without a peridevice thrombus.However, it was also noted that >20 saline bubbles still crossed the remnant pfo channel during the valsalva maneuver.The patient was advised to refrain from diving but was non-compliant.On an unknown date 8 months post pfo closure, the patient experienced headache, painful sensation in the hands and feet, and skin rash and pruritus in both feet due to recurrent decompression illness.The patient underwent hyperbaric oxygen chamber therapy.The article concluded that this case indicates that the risk of dci may remain even after pfo closure.The incomplete closure of pfo due to delayed endothelialization around the device, decompression sickness, and arterial gas embolism through the pulmonary circulation should be considered.Divers should be educated on maintaining a conservative diving protocol to decrease nitrogen gas load, and avoiding some measures to promote arterial embolization of nitrogen bubbles by increasing rap during ascent.[the primary and corresponding author was hyun-jong lee, division of cardiology, department of internal medicine, sejong general hospital, 91-121 sosa 2-dong, sosa-gu, bucheon 14574, republic of korea, with corresponding email: untouchables00@hanmail.Net].

• 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: 18889662
• Report Number: 2135147-2024-01096
• Device Sequence Number: 12660298
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: 02/20/2024
• Initial Report FDA Received Date: 03/12/2024
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male