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

Catalog Number	9-PDAP-05-02-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/25/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2024, a 5mm by 2mm amplatzer piccolo occluder was selected for implant in a 43 day old, 1.12 kg patient with a patent ductus arteriosus.The device was successfully implanted with no complications.After the procedure, the patient returned to the neonatal intensive care unit (nicu).On (b)(6) 2024, there was concern that the device had migrated due to low diastolic blood pressure, hypotension, and loud murmur.On echocardiography, a small left-to-right residual shunt was visualized.Mild aortic stenosis was noted.On (b)(6) 2024, a bedside paracentesis was performed to collect fluid for studies.It was noted that the patient had disseminated intravascular coagulation and received multiple latelet infusions.Exploratory laparotomy showed a massive amount of intraabdominal blood that was evacuated.The patient had a progressive deterioration following the paracentesis, including having hypotension and acidemia.The patient passed away.The primary cause of death was disseminated intravascular coagulation (dic).The secondary causes of death were unrelenting intra-abdominal bleeding, severe cholestasis presumed secondary to prolonged total parenteral nutrition (tpn), early chronic lung disease complicated by pulmonary hypertension, enterococcus bacteremia with persistent systemic inflammatory response, extreme prematurity.There was no allegation of malfunction against the implanted abbott device.
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 migration, residual shunt, hypotension, aortic valve stenosis, and death was reported.A returned device inspection, to rule out any device-related causes, 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 defined manufacturing specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information and medical review, the cause of the reported device migration and residual shunt could not be conclusively determined.It is possible sizing of the device could have contributed to the event; however, this could not be confirmed.It is likely that the patient¿s death was related to underlying medical conditions and the prematurity of the infant; however, this also could not be conclusively determined.In the course of the complaint investigation it was identified that the device was conforming and there were no allegations of a device deficiency from the user; however, a capa was requested per management discretion to document the details of the investigation and assess if there are any contributing factors or need for additional actions.

• 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: 20215935
• Report Number: 2135147-2024-04492
• Device Sequence Number: 7494302
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: (01)05415067031037(17)280229(10)8951951
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/22/2024

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-05-02-L
• Device Lot Number: 8951951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• 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: Death
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 1 KG