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

Catalog Number	9-PDAP-05-04-L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/07/2023
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) 2023, a 5mm by 4mm amplatzer piccolo occluder was chosen for implant for a 2 week old, 1.2kg patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter of 3.4mm, diameter at aortic ampulla of 3.6mm, and ductal length of 12mm.A series of follow up echocardiograms showed a stable left pulmonary artery (lpa) gradient of approximately 10/12mmhg (15-17m/sec).On 07 september 2023, the echocardiogram demonstrated severe lpa obstruction.The patient was referred for further intervention.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of severe lpa obstruction and device migration was reported.A review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, the recommended size devices for patients >2kg have a maximum duct length of 8mm, and therefore the 12mm patent ductus arteriosus length of the reported event falls outside recommended sizing.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 potentially be related to the user not following the recommended sizing chart provided in the ifu.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2023, a 5mm by 4mm amplatzer piccolo occluder was chosen for implant for a 2 week old, 1.2kg patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter of 3.4mm, diameter at aortic ampulla of 3.6mm, and ductal length of 12mm.A series of follow up echocardiograms showed a stable left pulmonary artery (lpa) gradient of approximately 10/12mmhg (15-17m/sec).On (b)(6) 2023, the patient had an out-patient clinic visit, and an echocardiogram demonstrated severe lpa obstruction.The patient did not have any symptoms.The patient was referred for further intervention.On (b)(6) 2023, a heart catheter was performed, which showed that the device was in the ductus and at the mouth of the left pulmonary artery.The physician was unable to get into the lpa with a wire or catheter.Surgery was then scheduled for lpa arterioplasty.On (b)(6) 2023, the patient had rhinovirus with cough and nasal congestion, so the surgery was postponed.On (b)(6) 2023, the proximal portion of the device was removed.In the operating room, it was believed by the physician that the device may have migrated.The patient was hospitalized.The patient status was reported as stable.

• 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: 17860494
• Report Number: 2135147-2023-04274
• Device Sequence Number: 5730240
• 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: 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): 12/22/2023

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 Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 8484735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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: Other; Required Intervention
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 5 KG