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

Model Number	9-PDAP-03-04-L
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 3-4mm amplatzer piccolo occluder was selected for implant in a 2kg patient with a pda (minimal diameter=2.76mm, diameter at aortic ampulla=4.14mm and a length=13.88mm).The device was prepared for implanted and deployed intraductal.The delivery catheter was noted to be abutting the device while the delivery cable was unscrewed.The device was released from the delivery cable without difficulty; however, the end screw was observed to be touching the delivery catheter.While drawing back the delivery catheter with force, the device became unstable and embolized to the right pulmonary artery.The device was retrieved using a 3.5f 4-8mm "n snare." a 4-2mm amplatzer piccolo occluder (lot number: 7167698) was attempted for implant but was exchanged for a 4-4 amplatzer piccolo occluder to ensure stability of the device.The 4-4mm amplatzer piccolo occluder (lot number: 6800257) was successfully implanted and the patient is reported to be stable.Per the site, the patient remained stable throughout the procedure and no effusion, tricuspid or pulmonary insufficiency were reported.
Additional Manufacturer Narrative
The 3/4mm piccolo occluder reportedly embolized.The results of the investigation are inconclusive since the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, arten600042307 version a, the defect appeared to be undersized, as the correct size piccolo occluder for the measurements provided was 4/4mm.A 4/4mm occluder was subsequently implanted successfully.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.The stated interaction of the device with the delivery catheter and the sizing were likely contributing factors in the subsequent embolization; however, the definitive cause of the reported event could not be conclusively determined.
Additional Manufacturer Narrative
Correction information for d2 additional information for g4, g7, h2, h10.

• 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: 9372950
• Report Number: 2135147-2019-00363
• Device Sequence Number: 3244245
• Product Code: MAE
• UDI-Device Identifier: 05415067030986
• UDI-Public: 05415067030986
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• 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: 12/31/2023
• Device Model Number: 9-PDAP-03-04-L
• Device Catalogue Number: 9-PDAP-03-04-L
• Device Lot Number: 6800254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 11/10/2020
• Initial Report FDA Received Date: 11/25/2019
• 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: Required Intervention
• Patient Age: 74 DA