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

Model Number 9-PDAP-05-02-L

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body Embolism (4439)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2021, a 5/2 amplatzer piccolo occluder was selected for implant in a (b)(6) old patient weighing (b)(6) kgs with the following patent ductus arteriosus (pda) measurements: minimal diameter of 3.8mm and length of 4-4.5mm.During the procedure the device was implanted intraductal and during release the device embolized to a branch in the left pulmonary artery.The device snared and removed from the patient with no patient consequences.There was no clinically significant delay to the procedure and the patient remained hemodynamically stable.There was no other device implanted and the patient is currently stable.

Manufacturer Narrative

An event of embolization of the 5/2mm piccolo 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.The cause of the reported event could not be conclusively determined.A capa was initiated for further investigation on the device embolization, per internal procedures.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11691062
• MDR Text Key: 246225415
• Report Number: 2135147-2021-00147
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• 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
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 7626594
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Weight: 2