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

Model Number 9-PDAP-05-04-L

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

An event of migration was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The selection of the correct device size could not be confirmed with the information provided.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 cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a 5-4 amplatzer piccolo was selected for implant for a 20 months old patient with a patent ductus arteriosus (pda) dimension of: 2.5 mm diameter, 7.4mm aortic ampulla, and 9.1mm length.The deviel was placed intraductal.Post device deployment, the device migrated to the right pulmonary artery.The device was snared and successfully retrieved.A 4-4 amplatzer adoii was implanted successfully instead.The physician noted that the device sizing was correct, however, the piccolo device was softer and therefore did not stayed in the pda.The patient is currently stable with no complications post procedure.

Manufacturer Narrative

Correction information for d2 additional information for g4, g7, h2, h10.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9695181
• MDR Text Key: 178773627
• Report Number: 2135147-2020-00054
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 9-PDAP-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 7007532
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 MO