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

Catalog Number UNK AMPLATZER PICCOLO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Date 12/20/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled ¿transcatheter closure of patent ductus arteriosus in preterm infants: results from a single-center cohort"na.

Event Description

The article, "transcatheter closure of patent ductus arteriosus in preterm infants: results from a single-center cohort", was reviewed.The article presented a case study of a 38-day-odl, 1045g infant with patent ductus arteriosus.It was reported that on an unknown date, an unknown amplatzer piccolor occluder was implanted.During procedure, it was noted there was severe left pulmonary artery stenosis and traumatic tricuspid regurgitation.A decision was made to retrieve the occluder but was unsuccessful.Within the first 24 hours post-procedure, the patient developed transient post-pda ligation syndrome.A second transcatheter attempt to recapture the occluder was made 48 hours post-procedure but was also unsuccessful.A lesion through the right ventricle infundibulum caused a tamponade leading to an emergency drainage surgery and ductal ligation.It was reported the patient passed away shortly after.The study concluded that transcatheter closure of a pda is a valid alternative to surgical ligation due to its high success rate and low incidence of post-ligature syndrome.Nevertheless, they also report rare, although serious complications.[the primary and corresponding author was marion honnorat, hfme, hospices civils de lyon, bron, france, with corresponding email: marion.Honnorat@chu-lyon.Fr].

Manufacturer Narrative

As reported in a research article, transcatheter closure of patent ductus arteriosus in preterm infants results from a single-center cohort.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.From medical review: "the cause of death is procedure related most likely due to catheter and/or guidewire instrumentation during a second attempt to retrieve the occluder using a transcatheter approach.The exact cause for the lpa stenosis is unknown, but could be related to device positioning and/or migration following device release." literature attachment: transcatheter closure of patent ductus arteriosus in preterm infants results from a single-center cohort.

• 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: 18711966
• MDR Text Key: 335476052
• Report Number: 2135147-2024-00682
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER PICCOLO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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): Death
• Patient Age: 1 MO
• Patient Weight: 1 KG