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

Model Number	9-PDAP-03-02-L
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Death (1802); Embolism (1829)
Date of Event	10/11/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 4/2mm amplatzer piccolo occluder was selected for implant in a (b)(6) gestational, female patient weighing (b)(6)g.The pda was noted to be approximately 2mm at the minimal diameter and 3-3.2mm at the aortic ampulla (device placement: intraductal).The device was implanted and re-positioned; however, the echocardiographer noted the proximal disc was impinging on the lpa.The device was recaptured and a 3/2mm amplatzer piccolo occluder (lot number: 6961517) was implanted.The 3/2mm device embolized to the rpa and was successfully retrieved using a gooseneck snare.The first 4/2mm amplatzer piccolo occluder was successfully implanted with no migration.Following the release of the device, an ultrasound was performed and revealed damage to the tricuspid valve.The patient was unable to recover and was reported to have expired the same day.
Additional Manufacturer Narrative
The 3/2 piccolo occluder reportedly embolized after replacing a larger, 4/2mm occluder, which was noted to protrude into the left pulmonary artery.The 4/2 device was then re-implanted following the embolization.Damage to the tricuspid valve and patient death reportedly occurred later that day.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the measurements received from the field and instructions for use arten600042307 ver.A, the larger, 4/2mm device was correctly sized.Therefore the 3/2 device appeared to be undersized for the defect, which potentially contributed to the reported embolization.The damage to the tricuspid valve is consistent with damage during retrieval efforts.However, the definitive cause of the event remains unknown.
Additional Manufacturer Narrative
Correction information for common device name.Additional information for date received by manufacturer, adverse event, if follow-up, what type?, additional mfg narrative.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9296674
• Report Number: 2182269-2019-00193
• Device Sequence Number: 2374277
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: 05415067030979
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2020

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: 03/31/2024
• Device Model Number: 9-PDAP-03-02-L
• Device Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 6961517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 11/10/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/16/2020; 12/20/2020
• 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: Death; Required Intervention
• Patient Age: 14 DA
• Patient Weight: 1