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

Model Number	9-PDAP-03-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of embolization of the 3-4 piccolo device was reported.A more comprehensive assessment could not be performed as 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 b, the correct size piccolo occluder for the measurements provided was a 3-4 piccolo,consistent with the embolized device, placed intraductal, not extraductal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined, however the placement of the device in the extraductal position could have contributed to the device embolization.A capa was initiated for further investigation on the device embolization, per internal procedures.Please note, per the arten600042307 version b "use the pda measurements to find the appropriate occluder size in t2 for patients >2 kg.Note: for small infants (=2 kg), the length of the occluder may be shorter than the length of the pda to minimize the potential for protrusion into the aorta or left pulmonary artery.For small infants, find the appropriate occluder size in t3.For small infants, the occluder is chosen so that the entire device including the retention discs is implanted within the duct (intraductal placement).".
Event or Problem Description
On (b)(6) 2020, a 3/4 amplatzer piccolo occluder was selected for implant in a (b)(6) day old, (b)(6) kg patient with patent ductus arteriosus dimensions of: minimal diameter of 1.5mm, length of 13.3mm, and a diameter at aortic ampulla of 3.3mm.The device was placed extraductal, but was determined to be mis-sized.The 3/4 amplatzer piccolo occluder was released and seconds later it embolized into the patient's pulmonary artery.The device was retrieved using a transcatheter snare and exchanged for a 4/4 amplatzer piccolo occluder.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.The patient is currently stable, healthy and discharged.
Additional Manufacturer Narrative
The report was submitted under the incorrect product code.The correct product code is mae.

• 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: 10440106
• Report Number: 2135147-2020-00375
• Device Sequence Number: 16856364
• Product Code: MAE
• UDI-Device Identifier: 05415067030986
• UDI-Public: 05415067030986
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 6836758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: 62 DA
• Patient Weight: 2