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

Model Number	9-PDAP-04-02-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Pulmonary Dysfunction (2019); Renal Failure (2041); Obstruction/Occlusion (2422); Foreign Body Embolism (4439)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2021, a 4/2 amplatzer piccolo occluder was selected for implant in a (b)(6) day old (b)(6) kg patient that was critically ill with respiratory failure and renal insufficiency.The patient had the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 2.4mm, pda length of 8.2mm and diameter at aortic ampulla of 3.3mm.During the procedure the device was successfully placed intraductally near the aortic end of the pda without impingement on the pulmonary artery (pa) or aorta.5 days post implant, the patient presented with symptomatic aortic obstruction, left ventricle (lv) dysfunction, and renal failure.The patient was taken back to the cath lab and it was found that the device had migrated such that the aortic disc and part of central disc were pushing into aorta, not allowing for the use of a stent.The device couldn't be removed or coarctation stented by transcatheter approach, so device was removed surgically.The pda was ligated and the aorta repaired.No residual pda or coarctation was noted by echo post pda device removal.The patient is recovering but is critically ill, as they were prior to the procedure.No additional information was provided.
Additional Manufacturer Narrative
An event of migration of device was reported.A more comprehensive assessment could not be performed, as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation into complaints regarding embolization and migration of piccolo occluder, per internal procedures.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12013548
• Report Number: 2135147-2021-00245
• Device Sequence Number: 11921390
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 08/06/2021

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: 09/30/2025
• Device Model Number: 9-PDAP-04-02-L
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 7710451
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 27 DA
• Patient Weight: 1