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

Model Number	OCCLUDER
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	10/11/2022
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 3m x 4mm amplatzer piccolo occluder, lot 8462779, was chosen for implant in a 1.2 kg patient with unknown patent ductus arteriosus (pda) dimensions.The device was placed within the pda using an abbott delivery system, and the occluder was released in the intraductal placement.Following release, the device embolized into the left pulmonary artery during procedure before leaving the catheterization laboratory, and the device position was determined by fluoroscopic evaluation.The embolized occluder was emergently snared and removed.A 4mm x 2mm amplatzer piccolo occluder, lot 8421936, was then successfully implanted.Following the procedure, a transthoracic echocardiogram (tte) was performed and there was moderate tricuspid regurgitation noted, to be monitored.The physician reported that the cause of embolization is due to device under sizing.The patient remained hemodynamically stable throughout the procedure.The patient status was reported to be stable.
Event or Problem Description
It was reported that on 11 october 2022, a 3m x 4mm amplatzer piccolo occluder, lot 8462779, was chosen for implant in a 1.2 kg patient with unknown patent ductus arteriosus (pda) dimensions.The device was placed within the pda using an abbott delivery system, and the occluder was released in the intraductal placement.Following release, the device embolized into the left pulmonary artery during procedure before leaving the catheterization laboratory, and the device position was determined by fluoroscopic evaluation.The embolized occluder was emergently snared and removed.A 4mm x 2mm amplatzer piccolo occluder, lot 8421936, was then successfully implanted.Following the procedure, a transthoracic echocardiogram (tte) was performed and there was moderate tricuspid regurgitation noted, to be monitored.The physician reported that the cause of embolization is due to device under sizing.The patient remained hemodynamically stable throughout the procedure.The patient status was reported to be stable.Subsequent to the previously filed report, additional information was received that the patent ductus arteriosus (pda) dimensions were: 2.6mm minimal diameter, 10.6mm length.
Additional Manufacturer Narrative
An event of device embolization was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.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 the device was undersized, which was confirmed with a review of the instructions for use, which could have contributed to the device embolization.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15752765
• Report Number: 2135147-2022-01976
• Device Sequence Number: 19547807
• Product Code: MAE
• UDI-Device Identifier: 05415067030986
• UDI-Public: 05415067030986
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 01/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-03-04-L
• Device Lot Number: 8462779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ABBOTT DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 DA
• Patient Sex: Female
• Patient Weight: 1 KG