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

Model Number Occluder

Device Problem Malposition of Device (2616)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 294903057
• Report Number: 2135147-2022-00379
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 DA
• Patient Sex: Male
• Patient Weight: 3 KG