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

Catalog Number UNK AMPLATZER PICCOLO

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Sepsis (2067); Tachycardia (2095); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453); Respiratory Insufficiency (4462)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effects of death and malfunctions reported in the article are captured under separate medwatch reports.Summarized patient outcomes/complications of closure of a patent ductus arteriosus with occluders, including the amplatzer piccolo occluder were reported in a research article.Some of the complications reported were device embolization, aortic obstruction, depressed cardiac output, systemic arterial thrombosis, atrial arrhythmia, hypotension, hypoxia, medication error, post-extubation stridor, respiratory distress, sinus tachycardia, tricuspid regurgitation, vessel trauma, device malposition, respiratory arrest, post ligation syndrome, urosepsis, surgical intervention, and death.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.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.

Event Description

The article, ¿safety and short-term outcomes for infants < 2.5 kg undergoing pda device closure: a c3po registry study¿, was reviewed.The article presents a multi-center retrospective study to evaluate short-term procedural outcomes and safety for infants < 2.5 kg who underwent catheterization with intended patent ductus arteriosus (pda) device closure.Devices included were amplatzer piccolo occluder, amplatzer duct occluder, micro vascular plug, and amplatzer vascular plug.The article concluded transcatheter pda closure in small infants can be performed with excellent short-term outcomes and safety across institutions with variable case volume.Increased risk of adverse events is associated with patients that have non-cardiac problems as well as the use of multiple devices during a case.[the primary and corresponding author is oliver barry, division of pediatric cardiology, new york-presbyterian ¿ morgan stanley children¿s hospital, columbia university medical center, 3959 broadway, chn-253, new york, ny 10032, usa, with corresponding email: omb2104@cumc.Columbia.Edu].

• 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: 17651347
• MDR Text Key: 322293922
• Report Number: 2135147-2023-03763
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/30/2023
• 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): Required Intervention; Life Threatening