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

Catalog Number	9-PDAP-03-02-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 3mm x 2mm amplatzer piccolo occluder was selected for an implant using a 4f amplatzer torqvue lp delivery system(tvlp) in a 6 week old preemie born on (b)(6) 2023 at 25 weeks gestation.The baby weighed 1.1 kilograms.The patent ductus arteriosus (pda) was measured on both transesophageal echocardiography (tee) and fluoro.The narrowest portion of the pda measure 2.0mm with a length of 8.4mm.The piccolo was placed intraductal via the 4f torqvue lp delivery system the piccolo was sitting more anterior in the duct, closer to the pa side.Upon release the device embolized to the lpa.The baby remained stable throughout the procedure.The physician used a non-abbott device to snare the piccolo into the sheath and removed from the body.The baby remained stable and the physician proceeded to measure the ductus and it was now measuring 2.5mm at the narrowest point.The physician then placed a 4mm x 2mm amplatzer piccolo occluder using the same 4f torqvue lp delivery system.The piccolo was placed intraductal and was successfully deployed.The baby remained stable throughout the case and was transferred back to the neonatal intensive care unit.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device embolization to the lpa and explant was reported.The embolized device was successfully retrieved by using non-abbott device to snare and removed from the body out of the lpa without issue.A review of the ductal measurements as reported from the field was performed.Images received appeared to show the amplatzer piccolo occluder within the ductus arteriosus placed in the intra-ductal position prior to release from the delivery cable.A returned device 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.

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17879048
• Report Number: 2135147-2023-04345
• Device Sequence Number: 7760701
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: 05415067030979
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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 Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 8625849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 WK
• Patient Sex: Female
• Patient Weight: 1 KG