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

Catalog Number	9-PDAP-04-02-L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Unspecified Infection (1930); Sepsis (2067); Respiratory Insufficiency (4462)
Date of Event	09/12/2024
Type of Reportable Event	Death
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) 2024, a 4mm x 2mm amplatzer piccolo occluder was selected for implant in a 20 days old patient with a weight of 642 grams.The patients condition prior to implant was critical and required ventilatory support on an oscillator, but stable prior to procedure.An umbilical venous catheter and an umbilical arterial catheter was placed at time of birth.A peripherally inserted central catheter (picc) line was also placed on (b)(6) 2024.The patient's pda measurements were: minimal diameter of 3.3mm, diameter at aortic ampulla of 5mm, and length of 9mm.The device was able to be successfully implanted intraductally with no issues pre-procedure, during procedure, or post-procedure.On (b)(6) 2024, the patient had a blood culture performed and revealed pseudomonas aeruginosa.On (b)(6) 2024, the patient became symptomatic with hypotension, desaturations, respiratory distress, bradycardia, and ended up passing away due to septic shock secondary to pseudomonas bacteremia.The physician couldn't determine whether the death was related to the implanted device.The last echocardiogram prior to death demonstrated the device to be in good position with no residual flow, no obstruction to flow in the aorta or left pulmonary artery.
Event or Problem Description
It was reported that on (b)(6) 2024, a 4mm x 2mm amplatzer piccolo occluder was selected for implant in a 20 day old patient with a weight of 642 grams.The patients condition prior to implant was critical and required ventilatory support on an oscillator, but stable prior to procedure.An umbilical venous catheter and an umbilical arterial catheter was placed at time of birth.A peripherally inserted central catheter (picc) line was also placed on (b)(6) 2024.The patient's pda measurements were: minimal diameter of 3.3mm, diameter at aortic ampulla of 5mm, and length of 9mm.The device was able to be successfully implanted intruducatally with no issues pre-procedure, during procedure, or post-procedure.On (b)(6) 2024, the patient had a blood culture performed and revealed pseudomonas aeruginosa.On (b)(6) 2024, the patient became symptomatic with hypotension, desaturations, respiratory distress, bradycardia, and ended up passing away due to septic shock secondary to pseudomonas bacteremia.The physician couldn't determine whether the death was related to the implanted device.The last echocardiogram prior to death demonstrated the device to be in good position with no residual flow, no obstruction to flow in the aorta or left pulmonary artery.
Additional Manufacturer Narrative
An event of death, hypotension, bradycardia, hypoxia, respiratory insufficiency, septic shock and pseudomonas bacteremia was reported.A returned device inspection, to rule out any device-related causes, 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 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 death appears to be related to septic shock and pseudomonas aeruginosa.The cause of the reported septic shock and pseudomonas aeruginosa could not be conclusively determined.The death is most likely related to an underlying patient condition.The reported hypotension, hypoxia, bradycardia, and respiratory insufficiency appears to be a cascading effect.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: 20445736
• Report Number: 2135147-2024-05077
• Device Sequence Number: 7995441
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: (01)05415067031006(17)290131(10)10219379
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/20/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 10219379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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: Female
• Patient Weight: 1 KG