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

Model Number	9-PDAP-04-02-L
Medical Device Problem Codes	Obstruction of Flow (2423); Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	Renal Impairment (4499)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2021, a 4/2 amplatzer piccolo occluder was selected for implant in a critically ill (b)(6) day old (b)(6) kg patient with the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 1.9mm, pda length of 7.3mm and diameter at aortic ampulla of 3.5mm.During the procedure, despite the device being appropriately sized, the patient experienced aortic impingement on multiple device deployments.Aortic imaging by ultrasound was extremely limited due to poor echo windows.On the final implant attempt the device was successfully positioned with no evidence of impingement on echo or by lower extremity arterial line waveforms, despite the pulmonary artery (pa) end of the device being moderately deformed.There was no clinically significant delay in procedure.Post procedure imaging was then performed and showed no evidence of aortic impingement.5 days later, the patient developed renal insufficiency and anuria.Echo was performed and showed significant device impingement of the aorta.Further imaging performed revealed that the aortic disc was extending into the aorta.It was then decided to place a 3.5 mm coronary stent which successfully relieved the aortic obstruction.The patient has since recovered from the pre-procedure state and is doing well.No additional information was provided.
Additional Manufacturer Narrative
An event of device impingement of the aorta and device deformation on the pulmonary artery end of the device was reported.A more comprehensive 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.Based on the information received, the cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation on the device migration, per internal procedures.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12005207
• Report Number: 2135147-2021-00243
• Device Sequence Number: 19685844
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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 Expiration Date: 09/30/2025
• Device Model Number: 9-PDAP-04-02-L
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 7721480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 DA
• Patient Weight: 1