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

Model Number	OCCLUDER
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, "aortic migration of amplatzer piccolo ductal occluder", was reviewed.The research article presents a case study on a 4 month old former 23 week premature baby, 610grams underwent device closure of a large patent ductus arteriosus in the cardiac catheterization lab with an amplatzer piccolo device at 2.4kg.He patent ductus arteriosus measured 2.5 mm at its narrowest dimension and 8.1 mm long and was closed using a 5-2 amplatzer piccolo occluder, based on the proctor¿s recommendation.Angiography during the procedure showed a device which sits largely intraductually.Intra-procedural transthoracic echocardiography showed no evidence of obstruction and hence the device was deployed in this position.Following the release of device part of the aortic disc protruded into the aorta while most of the device is still in the ductus.No attempt was made at retrieving or repositioning the device at this point since on echocardiogram there appeared to be no obstruction.Post procedure echocardiogram also showed no evidence of pulmonary or aortic obstruction 6 hours, 24 hours, and 1-week post-procedure.A follow-up echocardiogram performed 4 weeks post-procedure showed interval migration of the device into the aorta causing obstruction.The patient was taken back to the cardiac catheterization lab where significant obstruction with a peak gradient of 50 mmhg in the aortic isthmus was confirmed.Multiple attempts were made to snare the device from the pulmonary end but this was not successful since the pin and the full pulmonary disc were in the ductus.The aortic pin was snared and attempts were made to recapture the device and reposition it but the device could not be moved and instead the entire aorta moved with the device.The patient was transferred to our hospital for surgical removal of the device in light of the severe obstruction of the aorta.An echocardiogram performed at our institution confirmed severe obstruction of the aorta.The patient underwent removal of ductal device occluder, closure of the patent ductus arteriosus and repair of the left pulmonary artery and aorta at 18 weeks of life.The decision was made to perform the operation on cardiopulmonary bypass.The patent ductus arteriosus was dissected along its length and the device could be partially seen and felt from outside.Circulatory arrest was then initiated, and the patent ductus arteriosus was incised opened longitudinally to expose the pulmonary disc.The ductal tissue around the device was freed gently.The body of the piccolo device and the aortic end of the disc which had migrated well into the aortic lumen were gently freed of all adhesions.The device was then explanted in its entirety by traction on the pulmonary disc.Completion transesophageal echocardiogram demonstrated good ventricular function with a normal doppler pattern in the descending thoracic aorta.Following confirmation of hemostasis, the chest was closed.The patient did well in the post-operative period and follow-up echocardiograms continue to demonstrate normal ventricular function with no aortic obstruction.The article concluded that appropriate selection of device size is crucial for good outcomes.Aortic migration and obstruction are potentially serious complications of this device.Close and extended monitoring is required to diagnose this complication.[the primary and correspondence author is prashant k.Minocha, md, department of pediatric cardiology, nyu langone health, new york, ny 10016, email address: prashant.Minocha@nyulangone.Org].
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Summarized patient outcome/complication of amplatzer piccolo occluder implant was reported in a research article in a subject population with unknown co-morbidities.The complication reported was interval migration of the device into the aorta causing obstruction; this complication was 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.

• 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: 15505908
• Report Number: 2135147-2022-01408
• Device Sequence Number: 12065273
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: OCCLUDER
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/25/2022
• 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: Required Intervention
• Patient Age: 4 MO
• Patient Sex: Unknown
• Patient Weight: 1 KG