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

Model Number	9-PDAP-04-04-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Death (1802); Embolism (1829)
Date of Event	12/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2020, a premature (b)(6) old, (b)(6) patient underwent patent ductus arteriosus(pda) closure using a 4/4 amplatzer piccolo occluder.The patient had the following pda dimensions: minimal diameter of 3mm by angiogram (2.8 mm by echo), maximal diameter at aortic ampulla of 5mm and length of 10mm.During the procedure, the device appeared to be in very good position with no obstruction of the left pulmonary artery(lpa) descending aorta and no residual shunting.The device was subsequently released on cine guidance and initially was in very stable position.Follow-up echo demonstrated immediate embolization of the device into the right pulmonary artery(rpa) seconds following release.The physician retrieved the device with a 4 french terumo glide catheter and a 7 mm snare, but the device was unable to be retrieved into the 4 french terumo glide catheter and the device released from the snare and embolized into the rpa again.Subsequently, the physician used a 4 french flexor cook sheath and directed it into the rpa over a guidewire, but this resulted in a rpa perforation with subsequent fatality.
Additional Manufacturer Narrative
An event of embolization was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, 3 videos were received for analysis, which displayed the pda, the initial deployment and release of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined; however, review of the ifu sizing table, the recommended device based on the reported measurements was a 4/4 piccolo occluder, which may have contributed to the event.
Event or Problem Description
On (b)(6) 2020, a premature (b)(6) old, (b)(6) patient underwent patent ductus arteriosus (pda) closure using a 4/4 amplatzer piccolo occluder.Angiogram within the descending aorta demonstrated a pda that was slightly larger than expected at 3.5 mm in the mpa and 5.5 mm in the aortic end with a length of 12 to 14 mm.During the procedure, the device appeared to be in very good position with no obstruction of the lpa descending aorta and no residual shunting.The device was subsequently released on cine guidance and initially was in very stable position.Follow-up echo demonstrated immediate embolization of the device into the right pulmonary artery (rpa) seconds following release.The physician retrieved the device with a 4 french terumo glide catheter and a 7 mm snare, but the device was unable to be retrieved into the 4 french terumo glide catheter and the device released from the snare and embolized into the rpa again.Subsequently, the physician used a 4 french flexor cook sheath and directed it into the rpa over a guidewire, but this resulted in a rpa perforation with subsequent fatality.

• 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: 11152172
• Report Number: 2135147-2021-00012
• Device Sequence Number: 10929351
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 02/29/2024
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 6928418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/23/2021
• 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: Death; Life Threatening; Required Intervention
• Patient Age: 3 WK
• Patient Weight: 1