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); Premature Separation (4045)

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

Event Date 11/04/2022

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) 2022, a 4mm x 4mm amplatzer piccolo occluder was successfully implanted in a patient.The patient's patent ductus arteriosus (pda) had the following dimensions; length of 9mm and minimal ductus diameter of 3.5mm.It was noted via transesophageal echocardiogram (tee) and fluoroscopy, that after implant the occluder embolized into the patient's right pulmonary artery intra-procedurally.The decision was made to emergently snare the 4mm x 4mm amplatzer piccolo occluder.The 4mm x 4mm amplatzer piccolo occluder had been sized using fluoroscopic examination.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient did not have any clinical signs or symptoms during or after this event.The patient was stable at the time of report.There was no initial or prolonged hospitalization due to this event.There was no allegation of malfunction against the 4mm x 4mm amplatzer piccolo occluder or procedure.The cause of the occluder embolizing was due to the occluder becoming prematurely unscrewed/released from the delivery cable.

Event Description

It was reported that on 2022, a 4mm x 4mm amplatzer piccolo occluder was successfully implanted in a patient using an unknown delivery system.The patient's patent ductus arteriosus (pda) had the following dimensions; length of 9mm and minimal ductus diameter of 3.5mm.The 4mm x 4mm amplatzer piccolo occluder had been sized using fluoroscopic examination.During the procedure the delivery cable was not rotated during advancement or deployment.It was noted via transesophageal echocardiogram (tee) and fluoroscopy, that after implant the occluder embolized into the patient's right pulmonary artery intra-procedurally.The device did not occlude the patient's right pulmonary artery.The decision was made to emergently snare the 4mm x 4mm amplatzer piccolo occluder.The device was then successfully replaced with a 5mm x 4mm amplatzer piccolo occluder, using the same delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient did not have any clinical signs or symptoms during or after this event.The patient was stable at the time of report.There was no initial or prolonged hospitalization due to this event.There was no allegation of malfunction against the 4mm x 4mm amplatzer piccolo occluder or procedure.The cause of the occluder embolizing was due to the occluder becoming prematurely unscrewed/released from the delivery cable.Subsequent to the previously filed report, additional information was received that during the procedure the delivery cable was not rotated during advancement or deployment.The embolized device did not occlude the patient's right pulmonary artery.The device was then successfully replaced with a 5mm x 4mm amplatzer piccolo occluder, using the same delivery system.

Manufacturer Narrative

An event of embolization of the 4/4mm piccolo occluder was reported.A returned device assessment could not be performed as the device 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 specifications.Potential causes of embolization may include inadequate sizing or placement of occluder (anatomical or user technique) or patient related factors (physiological factors resulting in sudden increase in blood flow or ductal spasm).A review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, sizing chart , the recommended size devices for patients <2kg the appropriate sized occluder for the defect would have been a 5/2mm occluder.Based on the information received, the cause of the reported incident could potentially be related to the miss-sizing of the device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15848815
• MDR Text Key: 304174629
• Report Number: 2135147-2022-02194
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 8092046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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 Sex: Male
• Patient Weight: 1 KG