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

Catalog Number	9-PDAP-03-02-L
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that an unknown amplatzer piccolo occluder was selected for implant on (b)(6) 2021 using a 4f amplatzer torqvue low profile catheter.During implant the distal disc of the device was positioned out in the aorta and then the device was pulled into the patent ductus arteriosus (pda).The mid portion of the device was un-sheathed.It was noted that the distal disc was in the aorta and the connecting waist and proximal disc were in the pda at a sharp angle where some portion of the device passed through the ductus and into the aorta.The patient remained hemodynamically stable but the physician expressed concern of a connection made from the pda to the aorta through the superior aspect of the pda with the connecting waist and proximal disc closing the pda.The delivery system appeared to have crossed the top of the pda, through the pda wall, and through the anterior aortic wall into the lumen of the aorta.It was unknown if the device tore the superior aspect of the ampulla and pda or whether there was a puncture during the subsequent deployment, re-capture, and re-deployment.The patient was monitored for a considerable amount of time.No attempt was made to readjust the device.The device was implanted.X-ray imaging showed the the distal disc of the device in the aorta outside through the superior aspect of the pda.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device migration was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The fluoroscopy images show the device with the aortic disc in the aorta, but there is no evidence of disruption of the ductus arteriosus or aorta.The device is repositioned to become intra-ductal and confirmed with a ct scan image.There were no reported adverse patient consequences and no allegation the device malfunction.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19316074
• Report Number: 2135147-2024-02185
• Device Sequence Number: 6335304
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: (01)05415067030979(17)240930(10)7247248
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 7247248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2019
• 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: Other
• Patient Sex: Unknown