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 Hypoxia (1918); Obstruction/Occlusion (2422)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 5mm x 4mm amplatzer piccolo occluder was selected for implant in a 4.3kg, 46 day old patient with the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 3.1-3.2mm, pda length of 7-9mm, pda diameter at the aortic ampulla 7.88mm.The delivery system was an unknown abbott delivery system.Given the large aortic ampulla, the decision was made to use a 5/4 piccolo occluder instead of the recommended 5/6 piccolo occluder.It was decided to use a shorter device to allow apposition of the distal disc.Transthoracic echocardiography (tte) was used during procedure.The device was deployed a couple of times.On tte and fluoroscopy, there was no impingement on the left pulmonary artery (lpa) or the aorta, and there was no residual shunt through the device.The piccolo pulse checklist was utilized.A push pull test was performed, and there was no movement of the device.The device was released from the delivery cable.The patient had a subsequent procedure for esophageal dilation.Prior to dilation, the device was still in place.After the esophageal dilation was performed, the patient needed to be reintubated.It was noted that the device had embolized to the lpa and caused a partial obstruction.The device was successfully retrieved via transcatheter snare out of the lpa without issue.The physician stated that the cause of the device embolization was believed to be due to the esophageal dilation.The patient status was reported as stable.

Manufacturer Narrative

An event of device embolization to the lpa causing partial obstruction after esophageal dilation was reported.It was also reported that 5-4 mm device was used instead of recommended 5-6 mm piccolo device due to the large aortic ampulla, to allow apposition of the distal disc.A review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, arten600042307-d, sizing chart t2, the recommended device is 5-6 mm amplatzer piccolo occluder.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.Information from field indicated that the cause of the device embolization was believed to be due to the esophageal dilation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6) 2023, a 5mm x 4mm amplatzer piccolo occluder was selected for implant in a 4.3kg, 46 day old patient with the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 3.1-3.2mm, pda length of 7-9mm, pda diameter at the aortic ampulla 7.88mm.The delivery system was an unknown abbott delivery system.Given the large aortic ampulla, the decision was made to use a 5/4 piccolo occluder instead of the recommended 5/6 piccolo occluder.It was decided to use a shorter device to allow apposition of the distal disc.Transthoracic echocardiography (tte) was used during procedure.The device was deployed a couple of times.On tte and fluoroscopy, there was no impingement on the left pulmonary artery (lpa) or the aorta, and there was no residual shunt through the device.The piccolo pulse checklist was utilized.A push pull test was performed, and there was no movement of the device.The device was released from the delivery cable.The patient had a subsequent procedure for esophageal dilation.Prior to dilation, the device was still in place.After the esophageal dilation was performed, the patient needed to be reintubated.It was noted that the device had embolized to the lpa and caused a partial obstruction.The device was successfully retrieved via transcatheter snare out of the lpa without issue.The physician stated that the cause of the device embolization was believed to be due to the esophageal dilation.The patient status was reported as stable.

• 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: 17720802
• MDR Text Key: 323090467
• Report Number: 2135147-2023-03919
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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
• Device Lot Number: 8132126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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
• Patient Age: 46 DA
• Patient Weight: 4 KG