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

Model Number OCCLUDER

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 4mm by 4mm amplatzer piccolo occluder was chosen for implant in a 5-week old, 1.8 kg patient.During procedure, the device was implanted.A few minutes after the device was released from the delivery cable, the device embolized.The device was then successfully retrieved and removed from the patient.The patient status was reported as stable.

Manufacturer Narrative

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

Event Description

Subsequent to the previously filed report, additional information was received that an abbott delivery system was used to implant the 4mm by 4mm amplatzer piccolo occluder (lot 6816151).The patent ductus arteriosus (pda) dimensions were minimal diameter 3.2 mm, length of 8 mm, and diameter at aortic ampulla of 4.4 mm.The device was placed intraductal.After the device completely dislodged from the implant site, the device travelled to the patient's left pulmonary artery.The device was retrieved via transcatheter snare.The device was replaced with a 5mm by 2mm amplatzer piccolo occluder (lot unknown).The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The physician was aware that the recommended sizing per instructions for use (ifu) of the amplatzer piccolo occluder was 4mm by 2mm, but the other sized devices were chosen due to patient anatomical variation and physician preference.The other sized devices, the 4mm by 4mm amplatzer piccolo occluder and then the 5mm by 2mm amplatzer piccolo occluder, were chosen instead because it was believed that the longer length of the device would have more tissue contact with the pda.

Manufacturer Narrative

An event of embolism of a 4/4mm piccolo device was reported.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 and no similar complaints were found in a review of complaints on the batch.Based on the information received, the cause of the reported incident could not be conclusively determined; however the miss-sizing of the device could have contributed to the reported embolization.There is no indication of a product quality issue with regards to manufacture design or labeling.Please note, per the sizing table in the instructions for use, the recommended size device for a pda of a minimal diameter of 3.2mm, aortic ampulla diameter of 4.4mm and pda length of 8mm was a 4/2mm.

• 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: 15393612
• MDR Text Key: 299597946
• Report Number: 2135147-2022-01075
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 6816151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• 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: 5 WK
• Patient Sex: Male
• Patient Weight: 2 KG