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

Catalog Number 9-PDAP-05-04-L

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2023

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 2mm amplatzer piccolo device was chosen for implantation into a 7 week old 1.4 kilogram patient.The 5mm x 2mm was determined to be too small so a 5mm x 4mm amplatzer piccolo was attempted to be implanted.The device was deployed but after release from the cable it migrated.The device was snared and removed.The patient remained stable throughout the procedure.No further devices were attempted and the patient underwent surgical ligation of the patent ductus arteriosus on (b)(6) 2023.

Manufacturer Narrative

An event of device embolization to the left pulmonary artery and explant was reported.The embolized device was successfully retrieved by snare and removed from the body out of the lpa without issue.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.Based on the information received, the root cause of the reported incident could not be conclusively determined.However, it was noted that patient's pda was too large to be closed with available piccolo devices.

Event Description

It was reported that on (b)(6) 2023, a 5mm x 2mm amplatzer piccolo device was chosen for implantation into a 7 week old 1.4 kilogram patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter 4.2 mm, length of 8 mm, and diameter at aortic ampulla of 5 mm.Sizing was determined via angiogram.The 5mm x 2mm was advancing to the pda, but it seemed unstable due to mis-sizing so a 5mm x 4mm amplatzer piccolo was attempted to be implanted.The device was implanted and stable on fluoroscopy imaging, but by the time echocardiographic imaging was brought up to confirm positioning, the device had completely dislodged and traveled to the left pulmonary artery.There was no obstruction of blood flow.The device was snared and removed.The patient remained stable throughout the procedure.There was no clinically significant delay and no patient consequences.No further devices were attempted and the patient underwent surgical ligation of the patent ductus arteriosus on (b)(6) 2023.The physician thought the patient's pda was too large to be closed with available piccolo devices.

• 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: 18092462
• MDR Text Key: 327633000
• Report Number: 2135147-2023-04917
• Device Sequence Number: 1
• Product Code: MAE
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 7026235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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: 7 WK
• Patient Sex: Female
• Patient Weight: 1 KG