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

Model Number	OCCLUDER
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
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) 2022, a 5 mm x 2 mm amplatzer piccolo occluder was chosen for implant.Prior to the procedure an x-ray was performed and right lung haziness with possible abdominal pneumatosis was noted.The pda minimal diameter was sized to be 3.5mm.The diameter at aortic ampulla was measured to be 5.0mm.The device was placed intraductally and released.The following morning the echocardiogram and chest x-ray confirmed placement was satisfactory and that there was no flow through the duct.Also, right and left ventricular appeared normal and there was no sign of pulmonary hypotension.Later that evening, there was blood seen in nasogastric tube (ngt) or orogastric tube (ogt) and a pulmonary hemorrhage was suspected.The patient went into arrest and passed away on (b)(6) 2022.There was no defect or thrombus observed on the device during the patient autopsy.No additional information was provided.
Additional Manufacturer Narrative
An event of patient death due to pulmonary hemorrhage was reported.Information from the field indicated that the device was in a good position, with no defect or thrombus found at autopsy.It was reported that the patients death was due to pulmonary hemorrhage in the right lower lobe of the lung, with evidence of diffuse bronchopneumonia with heavy growth of staphylococcus aureus.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - clinical code: code 1888 removed.H6 health effect - impact code: code 1802 removed.H6 medical device problem code: code 2993 removed.
Event or Problem Description
It was reported that on (b)(6) 2022, a 5 mm x 2 mm amplatzer piccolo occluder was chosen for implant.Prior to the procedure an x-ray was performed and right lung haziness with possible abdominal pneumatosis was noted.The pda minimal diameter was sized to be 3.5mm.The diameter at aortic ampulla was measured to be 5.0mm.The device was placed intraductally and released.The following morning the echocardiogram and chest x-ray confirmed placement was satisfactory and that there was no flow through the duct.Also, right and left ventricular appeared normal and there was no sign of pulmonary hypotension.Later that evening, there was blood seen in nasogastric tube (ngt) or orogastric tube (ogt) and a pulmonary hemorrhage was suspected.The patient went into arrest and passed away on (b)(6) 2022.There was no defect or thrombus observed on the device during the patient autopsy.No additional information was provided.Subsequent to the initially filed report, the following information was received that the patient had a pulmonary hemorrhage in the right lower lobe of the lung, with evidence of diffuse bronchopneumonia with heavy growth of staphylococcus aureus (mrsa).Post patient death, the physician observed that the occluder was in good position and there was no noticed problem with the device.The patient's cause of death was not provided.No additional information was provided.

• Brand Name: AMPLATZER PICCOLO
• 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: 16044698
• Report Number: 2135147-2022-02710
• Device Sequence Number: 6238220
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-02-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: 12/03/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 01/26/2023
• 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: Death
• Patient Age: 5 WK
• Patient Sex: Male
• Patient Weight: 1 KG