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U.S. Department of Health and Human Services

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

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ABBOTT MEDICAL AMPLATZER PICCOLO; OCCLUDER, PATENT DUCTUS, ARTERIOSUS Back to Search Results
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].
 
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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 Key17651347
MDR Text Key322293922
Report Number2135147-2023-03763
Device Sequence Number1
Product Code MAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020024
Number of Events Reported1
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 NumberUNK 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 Received08/30/2023
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 Number1
Patient Outcome(s) Required Intervention; Life Threatening;
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