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

Model Number	OCCLUDER
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 5mm by 2mm amplatzer piccolo occluder was implanted into a patent ductus arteriosus (pda).The distal disc was noted to be close to the aorta.There was no defined coarctation of the aorta observed at the time of implant.After a 3 month follow-up on (b)(6) 2023, it was observed that there may be an aortic coarctation near the site of the implanted device that looks to be at the same height or level as the pda.The aorta immediately posterior to the pda has not grown or widened since the implant procedure as would be expected.Catheter films from the original implant were evaluated, and it was reported that an aortic coarctation may have already been present at the time of implant, but there was no pronounced tightening noted at the time of implant so this could not be confirmed and was only speculation.The echocardiogram study showed aortic flow was interrupted on the pda side with the piccolo device as well as the posterior wall of the aorta.The physician believed that the device may have migrated posteriorly towards the aorta/aortic ampulla due to pda constriction, which may be what was causing the turbulent flow near the piccolo side and posterior side of the aorta.The patient has good systemic flow distally.The patient has continued to gain weight since the procedure and has not experienced any hemodynamic consequences.There were no reported adverse patient consequences.The patient will continue to be monitored in-patient and receives routine imaging.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of aortic coarctation near the site of the implanted device and device migration was reported.A returned device assessment could not be performed as the device 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from field indicated that aortic coarctation was suspected to have already been present at the time of implant.Please note that, per the amplatzer piccolo occluder instructions for use, "contraindications: coarctation of the aorta".

• 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: 16765590
• Report Number: 2135147-2023-01703
• Device Sequence Number: 6151604
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• 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: 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): 06/23/2023

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 Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 8265664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: 4 MO
• Patient Sex: Female
• Patient Weight: 3 KG