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

Catalog Number	9-PDAP-05-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Obstruction/Occlusion (2422)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a 5mm by 4mm amplatzer piccolo occluder was successfully implanted using a 4f amplatzer torqvue lp delivery system for a 1.2 kg patient with the following patent ductus arteriosus (pda) measurements: minimal diameter of 3.5mm, length of 11.3mm, and diameter at aortic ampulla of 4.5mm.It was indicated that the physician felt measurements and weight were "borderline" between device choices.Per physician downsizing was not an option.Original deployment had immediate embolization of this device, which was recaptured and repositioned with satisfactory results per physician.On (b)(6) 2022, echocardiogram showed obstruction on the left pulmonary artery (lpa) due to patient anatomy.The patient experienced difficulty breathing, requiring respiratory support.The patient underwent medical intervention; however, the physician was unable to cross into the lpa.On (b)(6) 2022, the patient underwent surgical lpa angioplasty.The patient was discharged and reported to be stable.
Event or Problem Description
It was reported that on (b)(6) 2022, a 5mm by 4mm amplatzer piccolo occluder (lot 8421938) was chosen for implant, using a 4f amplatzer torqvue lp delivery system for 30 days old, 1.2 kg patient with the following patent ductus arteriosus (pda) measurements: minimal diameter of 3.5mm, length of 11.3mm, and diameter at aortic ampulla of 4.5mm.It was indicated that the physician felt measurements and weight were "borderline" between device choices.Per physician downsizing was not an option.Original deployment had immediate embolization of this device that was confirmed in fluoroscopy, which was retrieved via 10mm gooseneck snare, and removed from the patient.A replacement 5mm by 4mm amplatzer piccolo occluder (lot 8160390) was successfully implanted with satisfactory result per physician.On (b)(6) 2022, echocardiogram showed obstruction on the left pulmonary artery (lpa) due to patient anatomy.The patient experienced difficulty breathing, requiring respiratory support.The patient underwent medical intervention; however, the physician was unable to cross into the lpa.On (b)(6) 2022, the patient underwent surgical lpa angioplasty.The patient was discharged and reported to be stable.
Additional Manufacturer Narrative
An event of difficulty breathing was reported.Field indicated that echocardiogram showed obstruction on the left pulmonary artery (lpa) due to patient anatomy which may have contributed to the reported event.Patient underwent surgical lpa angioplasty.A more comprehensive assessment could not be performed as the device remains implanted and 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.H6 medical device problem code: code 1395 and 2017 removed.

• 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: 17652204
• Report Number: 2135147-2023-03770
• Device Sequence Number: 6510439
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/19/2023

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 8160390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 30 DA
• Patient Sex: Male