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

Catalog Number	9-PDAP-04-02-L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
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) 2024, a 4 mm x 2 mm amplatzer piccolo occluder was chosen for implant in a 1.2kg, 33 week old patient using a 4f amplatzer torqvue low profile catheter.The device was implanted.The following day after implant, a small residual shunt with mild left pulmonary artery (lpa) obstruction was observed via echocardiogram (echo).There was no negative clinical outcomes for the baby at present, only echo findings being watched.The shunt closed spontaneously post-operative day 23, and the patient was reported stable.
Additional Manufacturer Narrative
An event of patient device interaction problem (residual shunt) and obstruction/occlusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that a piccolo occluder was implanted.Later on, a small residual shunt with mild left pulmonary artery (lpa) obstruction was observed via echocardiogram (echo).The shunt closed spontaneously post-operative day 23.The patient is stable.Based on the information received, a 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
It was reported that on (b)(6) 2024, a 4 mm x 2 mm amplatzer piccolo occluder was chosen for implant in a 1.2kg, 33-week-old patient using a 4f amplatzer torqvue low profile catheter.The device was implanted.The following day after implant, a small residual shunt with mild left pulmonary artery (lpa) obstruction was observed via echocardiogram (echo).There was no negative clinical outcomes for the baby at present, only echo findings being watched.The shunt closed spontaneously post-operative day 23, and the patient was reported stable.

• 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: 19265765
• Report Number: 2135147-2024-02051
• Device Sequence Number: 6981572
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: (01)05415067031006(17)280430(10)9030561
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 9030561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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: 7 MO
• Patient Sex: Unknown
• Patient Weight: 1 KG