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

Catalog Number	9-PDAP-04-04-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	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 27 february 2024, a 4mm x 4mm amplatzer piccolo occluder was chosen for patent ductus arteriosus (pda) closure in a 3 month old preemie using a 4f amplatzer torqvue lp delivery system (tvlp).It was difficult to cross the pda and we suspected the ductus had spasmed.The pda was measured by transthoracic echocardiogram (tte) and fluoroscopy twice.The narrowest portion of the pda measure 3.0mm on the first angiogram and then 3.6mm on the 2nd angiogram.The length of the ductus was 11.1mm.The piccolo was sitting more anterior in the duct, closer to the pulmonary artery (pa) side.Upon releasing the piccolo, it was embolized to the right pulmonary artery (rpa), the patient remained stable throughout the procedure.The physician used non- abbott sheaths to snare the piccolo and removed form the body.The patient remained stable and they proceeded to measure the ductus and it was now measuring 3.3mm at the narrowest point.A new 5mm x 2mm amplatzer piccolo occluder and 4famplatzer torqvue lp delivery system was chosen, placed intraductal and successfully deployed.The patient remained stable throughout the case and was transferred back to the neonatal intensive care unit (nicu).Post procedure, patient need extra ventilation support 24 hours post procedure but were weened back down to lower levels within 48 hours.The patient was reported stable.
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 migration or expulsion of device (device embolization) was reported.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.Information from the field indicated that it was difficult to cross the pda and suspected the ductus had spasmed.Upon releasing the piccolo, it was embolized to the right pulmonary artery (rpa).The physician used non- abbott sheaths to snare the piccolo and removed form the body.A new 5mm x 2mm amplatzer piccolo occluder and 4famplatzer torqvue lp delivery system was chosen and implanted.Based on the information received, the cause for the reported device embolization could not be conclusively determined.The reported unexpected medical intervention was results of case-specific circumstances as the physician used a sheath to snare the piccolo and removed from the body.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18946294
• Report Number: 2135147-2024-01269
• Device Sequence Number: 18150404
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: (01)05415067031013(17)261231(10)8295541
• 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: 2024
• Device Explanted Year: 2024
• 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): 07/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 8295541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2022
• 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: 3 MO
• Patient Sex: Female
• Patient Weight: 2 KG