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

Catalog Number 9-PDAP-05-04-L

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Literature article: left pulmonary artery occlusion following device closure of patent ductus arteriosus in premature infants investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.

Event Description

The article, "left pulmonary artery occlusion following device closure of patent ductus arteriosus in premature infants", was reviewed.The article presented a case study of a 30-day-old, 1160g, male patient with comorbidities necrotizing enterocolitis (nec) with bowel resection, ileostomy, ventilator dependence, bronchopulmonary dysplasia (bpd), and poor nutrition.It was reported on an unknown date a 5-4mm amplatzer piccolo occluder was chosen for implant to occluder a patent ductus arteriosus (pda) with the following dimensions: narrowest diameter = 3.5mm, largest diameter = 4.5mm, and length = 11.3mm.After initial implant, it was noted the device embolized to the left pulmonary artery (lpa).A decision was made to retrieve the device and it was repositioned and implanted closer to the aortic end of the pda.It was then reported 9 weeks later on an unknown date, a transthoracic echocardiography (tte) showed a suprasystemic right ventricle and no flow to the lpa.A decision was made to perform surgical revascularization via pulmonary arterioplasty where it was noted the 5-4mm amplatzer piccolo occluder's proximal disc was intraductal with the lpa below and completely obstructing the flow.It was then reported three months following reintervention, the patient presented with severe restenois and a decision was made to perform stent angioplasty.The article concluded although rare, severe lpa obstruction can be seen in premature infants following device closure of the pda.The piccolo device is designed to ideally remain entirely intraductal.Although device selection appeared to provide a device short enough for the given ductal length, they recommend, whenever possible, giving consideration to using the shortest possible device.We also recommend increasing the frequency of echocardiographic surveillance to weekly studies if at any time the imaging demonstrates an increase in the degree of obstruction/turbulence.Clinicians should have a low threshold for alternative imaging modalities such as computed tomography or more invasive options if a pattern of increased obstruction is detected.This may allow for a transcatheter based intervention to either retrieve the device, if relatively soon, or stent the lpa, if patient size allows.[the primary and corresponding author was jesus jaile, children¿s hospital of new orleans / lsuhsc, new orleans, louisiana, with corresponding email: jesus.Jaile@lcmchealth.Org].

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer piccolo were reported in a research article in a subject population with multiple co-morbidities including necrotizing enterocolitis (nec) with bowel resection, ileostomy, ventilator dependence, bronchopulmonary dysplasia (bpd), and poor nutrition.Some of the periprocedural complications reported were device embolization, unexpected medical intervention, and improper use and post-procedural complications included surgical intervention, hospitalization, obstruction/occlusion, and hemorrhage ; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Per the instructions for use, it stated, " warnings: remove embolized devices.Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter.¿accurate measurements of the ductus are crucial for correct occluder size selection." this is considered as an improper or incorrect procedure or method of the device.However, it was unable to determine if an improper or incorrect procedure or method contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.

• Brand Name: AMPLATZER PICCOLO
• Type of Device: 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: 18120745
• MDR Text Key: 327999128
• Report Number: 2135147-2023-04966
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-PDAP-05-04-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 30 DA
• Patient Sex: Male