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

Model Number	OCCLUDER
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 4mm by 2mm amplatzer piccolo occluder was selected for implant in a 32 week, 1.7kg patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter 2.6mm, length of 9mm, and diameter at aortic ampulla of 3.4mm.The device was prepared per the ifu and implanted intraductally using a 4f 60cm amplatzer torqvue lp delivery system.It was observed during the procedure that the device migrated slightly and then embolized down to the abdominal aorta.The decision was made to emergently remove the device because it caused a gradient in the aortic arch.The physician then successfully snared the device and replaced it with another 4mm by 2mm amplatzer piccolo occluder (8474507).Temporary loss of perfusion to the right foot was reported and heparin was administered to treat it.The patient was reported as recovered and was discharged.The patient remained hemodynamically stable throughout the procedure.
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 embolism of the 4/2mm piccolo device was reported.The investigation confirmed the device met dimensional specifications when analyzed at abbott under non-physiological conditions.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, the correct size piccolo occluder for defect was a 4/2mm, the size of the embolized device.Information form the field indicated that the ifu was followed during the implant procedure.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 incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.

• 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: 15611711
• Report Number: 2135147-2022-01639
• Device Sequence Number: 2762449
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 8474507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE LP DS, 9-TVLP4F90/060.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 32 WK
• Patient Sex: Female
• Patient Weight: 2 KG