MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	Occluder
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Summarized patient outcomes/complications of amplatzer piccolo occluder were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were device protruded in left pulmonary artery and moderate tricuspid regurgitation; these complications are anticipated for the procedure and subject population.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.Please note that per the instructions for use, artmt600061587 rev.C, the correct size for the provided measurements was a 4-4 mm amplatzer¿ piccolo occluder, smaller than the implanted device.
Event or Problem Description
An article from the medical conference abstract magazine for (b)(6) society of congenital interventional cardiology, was reviewed.The research article presents a case study 9 days in age male, 3200g, krichenko type a, diameter of pulmonary atresia (pa) side for patent ductus arteriosus (pda ) 2.9mm, aortic root ( ao) side for pda 4.3mm, length of pda 5.5mm.An amplatzer piccolo occluder 5 mm x 4 mm was implanted on an unknown date and year, the device protruded in left pulmonary artery (lpa) no significant stenosis was observed.Novel moderate tricuspid regurgitation was also confirmed which might have caused by chordal rupture of tricuspid.At the time of one year after the surgery, tricuspid regurgitation has become mild.No vessel stenosis has observed and no additional information was available.[the author of the article is yoshiyuki kagiyama, md, (b)(6).

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 14689643
• Report Number: 2135147-2022-00379
• Device Sequence Number: 20485235
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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 Model Number: Occluder
• Device Catalogue Number: 9-PDAP-05-04-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/14/2022
• 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: Other
• Patient Age: 9 DA
• Patient Sex: Male
• Patient Weight: 3 KG