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

Model Number	DUCT OCCLUDER
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 10-8mm amplatzer duct occluder was successfully implanted in a patient.It was noted during procedure that there was a residual shunt detected via angiography examination after full deployment/implant of the occluder.The residual shunt was not considered the patient was checked again 24 hours after implant and an echocardiogram detected the same residual shunt.There was no intervention performed.The patient was stable and discharged at the time of report and told to call to schedule a follow up appointment a month after the implant procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of residual shunt 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 that the product met all specifications.Based on the information received, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regard to manufacture, design, or labeling.H6 health effect - clinical code: code 4580 removed.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the 10-8mm amplatzer duct occluder was sized using fluoroscopic examination.There had been no difficulty experienced implanting the occluder into the patient's patent ductus arteriosus.The occluder had been implanted using a 7f amplatzer torqvue delivery system.It presumed that the 10-8mm amplatzer duct occluder was missing it's standard polyester fabric, but still remains implanted.The 10-8mm amplatzer duct occluder was not mishandled or damaged during device preparation.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.There was no intervention required/performed for the residual shunt that persisted, but the patient will be re-evaluated during a 30 day follow up appointment.The patient was discharged at the time of report.

• Brand Name: AMPLATZER DUCT OCCLUDER
• 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: 16040518
• Report Number: 2135147-2022-02703
• Device Sequence Number: 4937205
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: 00811806011134
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 8305598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 02/12/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2022
• 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
• Patient Sex: Unknown