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

Model Number	OCCLUDER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	02/17/2023
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) 2023, a 5mm by 2mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue low profile catheter.The patent ductus arteriosus (pda) minimal diameter was measured to be 3.42mm.The pda diameter at the aortic ampulla was measured to be 3.50mm.The pda length was measured at 8.55mm.It was reported that the delivery catheter was too stiff and significantly manipulated the duct anatomy while attempting the place the device.A 4f non-abbott delivery system was used to access the pda via the right femoral vein approach.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.24 hours post procedure, it was observed that the patient experienced moderate tricuspid valve regurgitation via transesophageal echocardiogram (tee).On (b)(6) 2023, there was no noticeable tricuspid valve regurgitation seen on the tee.The patient was reported as stable and recovered.
Additional Manufacturer Narrative
An event of moderate tricuspid valve regurgitation 24 hours post procedure was reported.Information from the field indicated that tricuspid valve regurgitation was no longer noticeable on tee some weeks later.A more comprehensive assessment could not be performed as the device was not returned for analysis.However, information from the field indicated that the physician believed that the catheter significantly manipulated the duct anatomy during implantation and placed back pressure on the tricuspid valve during delivery which may have caused the latent injury that was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 16529632
• Report Number: 2135147-2023-01152
• Device Sequence Number: 19472167
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/25/2023

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
• Device Lot Number: 8452383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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: 30 WK
• Patient Sex: Female
• Patient Weight: 1 KG