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

Catalog Number 9-PDAP-04-02-L

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 04/26/2023

Event Type  Injury  

Event Description

The article, "late aortic obstruction due to ductal vasoconstriction on pulmonic end after transcatheter patent ductus arteriosus closure in an extremely low-birth-weight infant", was reviewed.The article presented a case study of a 21 day old premature infant with respiratory distress syndrome, necrotising enterocolitis, and patent ductus arteriosus (pda).It was reported that on an unknown date, a 4-2mm amplatzer piccolo occluder was chosen for implant with a 4f unknown delivery sheath.The patient's procedural weight was 980g and their pda measurements were 8.7-mm ductal length and a 2.6-mm minimal ductal diameter.After device release, echocardiography checked co-axial, intraductal device positioning, with no peri-device residual shunt and peak velocities < 1.2 m/s in both left pulmonary artery and descending aorta.Four weeks post-procedure, echocardiography showed device protrusion to descending aorta.At the eighth week post-procedure, the aortic obstruction was more pronounced and attributed to late device protrusion.At 4 months, the baby had gradually developed a symptomatic, acquired aortic coarctation.He underwent surgical coarctation repair through posterolateral thoracotomy, with end-to-end anastomosis without cardiopulmonary bypass.The aortic disk of the apo device was removed, and the aortic end of the ductus disconnected, with external ligation of the device into the duct to keep it firmly attached.The article concluded that ductal vasoconstriction at the pulmonic end may lead to delayed device-induced, clinically significant aortic obstruction after transcatheter patent ductus arteriosus closure in extremely low-birth weight infants.Being aware of that mechanism, clinicians should (a) strive to position the apo device intraductally with no uncovered patent ductus arteriosus segment at the pulmonic end in < 2 kg infants and (b) closely monitor the descending aorta velocities during at least the end of the first month after device implantation.The article concluded that ductal vasoconstriction at the pulmonic end may lead to delayed device-induced, clinically significant aortic obstruction after transcatheter patent ductus arteriosus closure in extremely low-birthweight infants.Being aware of that mechanism, clinicians should (a) strive to position the apo device intraductally with no uncovered patent ductus arteriosus segment at the pulmonic end in < 2 kg infants and (b) closely monitor the descending aorta velocities during at least the end of the first month after device implantation.[the primary and corresponding author was alban-elouen baruteau, centre hospitalier universitaire de nantes, 7 quai moncousu, 44093 nantes cedex 01, france, with corresponding e-mail: albanelouen.Baruteau@chu-nantes.Fr].

Manufacturer Narrative

Literature article: late aortic obstruction due to ductal vasoconstriction on pulmonic end after transcatheter patent ductus arteriosus closure in an extremely low-birth-weight infant.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer piccolo occluder were reported in a research article in a subject population with respiratory distress syndrome, necrotizing enterocolitis, and patent ductus arteriosus.Some of the complications reported were obstruction/occlusion, hospitalization, and surgical intervention.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Literature attachment: article title: "late aortic obstruction due to ductal vasoconstriction on pulmonic end after transcatheter patent ductus arteriosus closure in an extremely low-birth-weight infant" h6 medical device problem code: code 2017 removed.

• 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: 18653066
• MDR Text Key: 334689857
• Report Number: 2135147-2024-00531
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-PDAP-04-02-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization
• Patient Age: 21 DA