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

Model Number	9-PDAP-05-06-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
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 5/6 amplatzer piccolo occluder was selected for implant in a 35 day old 3 kg premature patient with the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 4 mm, pda length of 12 mm and diameter at aortic ampulla of 7 mm.During the procedure the device was placed intraductal, but soon after releasing the device from the delivery cable, the device embolized into the pulmonary artery.The device was successfully snared and removed from the patient.A 3 mm amplatzer duct occluder was then used and successfully implanted intraductally to resolve the event.The procedure was not extended longer than is clinically significant and the patient remained hemodynamically stable throughout.The patient is stable.No additional information was provided.
Additional Manufacturer Narrative
An event of device embolization was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.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.A capa was initiated for further investigation on the device embolization, 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: 12339090
• Report Number: 2135147-2021-00332
• Device Sequence Number: 14154724
• Product Code: MAE
• UDI-Device Identifier: 05415067031051
• UDI-Public: 05415067031051
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/22/2021

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: 03/31/2024
• Device Model Number: 9-PDAP-05-06-L
• Device Catalogue Number: 9-PDAP-05-06-L
• Device Lot Number: 6952114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: Required Intervention
• Patient Age: 35 DA
• Patient Weight: 3