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

Model Number 9-PDAP-04-04-L

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problem Embolism (1829)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned, and therefore a physical analysis related to the reported migration and embolization condition could not be completed.There were no observed artifacts related to the design, or assembly, or device acceptance inspections that indicate the design or the manufacture of the present occluder is the root cause of the observed device migration.The complaint device was retrieved without additional patient effects, and the next size larger device remained implanted.

Event Description

On (b)(6) 2020, a 4-4 amplatzer piccolo was selected for implant.The (b)(6) old, (b)(6) patient has the following pda dimension: ao: 4.36mm, mid: 2.14mm, pulmonary: 3.27mm, and length: 9.33mm.The device was implanted intraductal, but embolized from the duct to the left pulmonary artery 2 minutes after deployment.The device was snared and removed from the left pulmonary artery.The device was exchanged with a 5-4 piccolo and the device was successfully implanted.The patient is doing well with no reported adverse consequences.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: g4, g7, h2, h6, and h10.An event of device embolization was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis, and the investigation was limited to the device history record and reported dimensions of the pda taken during imaging in the field.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A review of the instructions for use arten600042307 rev.A sizing table t2 for patients greater than 2 kg found that the correct size for the reported pda was a 4-6 piccolo occluder.The under-sizing of the 4-4 occluder and causal relationship to the subsequent embolization could not be independently verified; however, a larger device was successfully implanted.

• 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: 10077674
• MDR Text Key: 191673386
• Report Number: 2135147-2020-00219
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 7079112
• Was Device Available for Evaluation?: No
• 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): Required Intervention
• Patient Age: 93 DA