MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PICCOLO OCCLUDER

Model Number	9-PDAP-05-06-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
(b)(6) baby with a patent ductus arteriosus (dimensions not provided) underwent transcatheter pda closure using the amplatzer piccolo occluder.The amplatzer piccolo occluder was delivered and released without difficulty.There was no post-procedure imaging assessment of the device position until a few weeks later when it was determined that the device embolized into the left pulmonary artery.The infant was asymptomatic and taken to the catheterization laboratory where the embolized device was retrieved using a transcatheter snare without difficulty.The pda was smaller in size and a decision was made to not attempt another device implant.
Additional Manufacturer Narrative
An event of embolization noted roughly 5 weeks following the procedure was reported.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 information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2019, a 5-6mm amplatzer piccolo occluder was selected for implant in a (b)(6)kg patient was a pda (minimal diameter: 3 mm, length: 7.7 mm ¿ 9.3 mm, diameter at aortic end: 6.3 mm).The device was placed in the aortic disc intra-ductal with the pa disc extra-ductal and was released without difficulty.No post-procedure imaging was performed initially.A few weeks following the procedure, the device was observed to have embolized into the left pulmonary artery.The infant was reported to be asymptomatic and on (b)(6) 2019, the device was removed using a transcatheter snare.The pda was observed to be smaller in size and no replacement device was implanted.The patient is reported to have been discharged.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: AMPLATZER PICCOLO OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9077739
• Report Number: 2135147-2019-00298
• Device Sequence Number: 2547584
• Product Code: MAE
• UDI-Device Identifier: 05415067031051
• UDI-Public: 05415067031051
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/11/2019

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: 01/31/2024
• Device Model Number: 9-PDAP-05-06-L
• Device Catalogue Number: 9-PDAP-05-06-L
• Device Lot Number: 6857097
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 2 MO
• Patient Weight: 3