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

Model Number	9-PDA-003
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
User facility medwatch received states, on (b)(6) 2021.A 3 mm amplatzer duct occluder was chosen for a patent ductus arteriosus (pda) closure procedure.During the procedure the device was positioned in the intended position and was released from the cable and the delivery system was removed from the patient.There was a shunt observed around the device on an echocardiogram.This caused concern and the user attempted to retrieve the device after implant.The device embolized during the retrieval process into the descending aorta.Several attempts were made, antegrade but due to the patients anatomy it was impossible.Next, manipulations were attempted and the device was repositioned within the ductus.A follow-up angiogram revealed the device was in a reasonable position within the ductal ampulla with a small residual shunt through the device, however, due to the original embolization of the device, it was not felt the position was stable and surgical intervention was required.The patient underwent the surgical removal of the amplatzer duct occluder.The surgeon found a large tortuous pda, and noted that the occluder device could be felt in the aorta at the isthmus, but was not occluding flow, and the lower extremity arterial pressure was normal.It was reported the patient remained stable throughout the procedure.The patient had an echocardiogram (echo) the following day which showed the ventricular function of the patient was normal without residual pda.Pediatric patient recovered quickly, and was discharged home 2 days later.
Additional Manufacturer Narrative
An event of residual shunt, device embolism, and surgical explant of the device was reported.A more comprehensive assessment could not be performed, as the device 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12116432
• Report Number: 2135147-2021-00235
• Device Sequence Number: 4304321
• Product Code: MAE
• UDI-Device Identifier: 00811806011103
• UDI-Public: 00811806011103
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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 Expiration Date: 10/31/2025
• Device Model Number: 9-PDA-003
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 7754442
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Weight: 7