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

Catalog Number UNK AMPLATZER PICCOLO

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Inflammation (1932); Renal Failure (2041); Sepsis (2067); Respiratory Insufficiency (4462)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Summarized patient outcomes/complications of patent ductus arteriosus closure with either surgical or closure with an amplatzer piccolo device were reported in a research article in a subject population with multiple co-morbidities including intracranial hemorrhage, seizures, post-hemorrhagic ventriculomegaly, early onset sepsis, dysmorphic facies, corpus callosal dysgenesis, cerebellar hypoplasia, rhizomelic limb shortening, retrognathia and small phallus.Some of the complications reported for closure with an occluder were device migration, surgical intervention, hospitalization, unexpected medical intervention (steroids for bronchopulmonary dysplasia), late-onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, acute kidney injury, intracranial bleed, lower limb thromboses, and patient death.These complications are anticipated for the procedure and subject population.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.

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, pediatricsdetroit, centralmi, usa with corresponding email: gnataraj@dmc.Org] the time frame of this study ranged from 01 january 2019 through 31 december 2021.The number of patients included in this study was 36 patients who underwent surgical ligation (sl) and 76 who underwent catheter-based closures (cc).For sl group, the average age just prior to procedure was 28.6 days, average gender was female, and average weight was 900 grams.For cc group, the average age just prior to procedure was 38.3 days, average gender was male, and average weight was 1211 grams.Comorbidities included: intracranial hemorrhage, seizures, post-hemorrhagic ventriculomegaly, early onset sepsis, dysmorphic facies, corpus callosal dysgenesis, cerebellar hypoplasia, rhizomelic limb shortening, retrognathia and small phallus.Post-procedural complications included: device migration, surgical intervention, hospitalization, unexpected medical intervention (steroids for bronchopulmonary dysplasia, late-onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, acute kidney injury, intracranial bleed, lower limb thromboses, and death.

• 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: 17291995
• MDR Text Key: 319035076
• Report Number: 2135147-2023-02960
• 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: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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): Life Threatening; Hospitalization; Required Intervention