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 Problem Insufficient Information (4580)

Event Date 01/01/2019

Event Type  Death  

Event Description

*the article, "comparative effectiveness of surgical ligation and catheter closure of patent ductus arteriosus in preterm infants", was reviewed.The article presents a retrospective, single-center experience to evaluate the association, if any, between closure modality (surgical ligation sl vs.Catheter cc) of a hemodynamically significant patent ductus arteriosus (pda), after failure of or contraindication to medical therapy, and immediate procedural complications, and post-procedure physiologic status in preterm (gestational age < 32 weeks) infants.All catheter-based closures were performed with the amplatzer piccolo device.The article concluded that the risks of serious adverse outcomes were low, regardless of the modality.Transcatheter closure of pda was comparable to surgical ligation; both procedures were effective and had few major adverse effects.Further investigation into long-term outcomes associated with both procedures is warranted.[the primary and corresponding author is girija natarajan, division of neonatology, central michigan university, children¿s hospital of michigan, 3901 beaubien blvd, pediatrics detroit, central mi, usa with corresponding email: gnataraj@dmc.Org].

Manufacturer Narrative

Patient outcome of death in the research article for patent ductus arteriosus closure with either surgical or closure with an amplatzer piccolo device was reported in a subject population with multiple co-morbidities.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.Based on the available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.(b)(6) 2023: death date is estimated (b)(6) 2021, the same date the study ended.

• 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: 17327743
• MDR Text Key: 319060612
• Report Number: 2135147-2023-03039
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 06/19/2023
• 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