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

Catalog Number	9-PDAP-05-02-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, a patient had an amplatzer piccolo device implanted which later embolized.It was also indicated that another amplatzer plug was implanted in the patent ductus arteriosus and that the piccolo was eventually removed from the patient after an unsuccessful attempt.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, ¿risk factors associated with device embolisation or malposition during transcatheter closure of patent ductus arteriosus¿, was reviewed.The article presented a case study of a 2 month old patient weighing 2.2 kg with down syndrome, high anorectal malformation (arm), near systemic pulmonary artery pressures and large pericardial effusion.It was reported that on an unknown date, a 5-2mm amplatzer piccolo occluder was chosen for implant to treat patent ductus arteriosus (pda) that was sized 4 mm.It was then reported on an unknown date, the device had embolized and initial attempts to retrieve the device had failed as the embolized device was deeply lodged into the smaller right lower lobe branch.A decision was made to implant an 8mm amplatzer vascular plug ii into the pda.After successful implant, it was reported the pericardial effusion was drained and the patient was conservatively observed for piccolo embolization.It was reported the piccolo was recovered uneventfully on an unknown date.The article concluded device embolisation complicates 4% of transcatheter duct closures, with need for surgery in one-fifth of them.Larger ducts with high pulmonary artery pressures in younger and smaller infants are more often associated with device embolisation.Tubular ducts are more prone for embolisation compared to usual conical ducts.Softer vascular plugs are often associated with embolisations.Intentional device under sizing to avoid vascular obstruction in small patients is a frequent risk factor for embolisation.Precise echocardiographic measurements, correct occluder choice, proper technique and additional care in patients with high pulmonary artery pressures are mandatory to minimise embolisations.[the primary and secondary author was kothandam sivakumar, madras medical mission, 4a dr jj nagar, mogappair, chennai 600089, india, with corresponding email drkumarsiva@hotmail.Com].

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: 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: 18278650
• Report Number: 2135147-2023-05348
• Device Sequence Number: 15004381
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-05-02-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 2 MO
• Patient Sex: Unknown
• Patient Weight: 2 KG