MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number	9-PDA-003
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of deployment of a mis-sized amplatzer duct occluder (ado), which subsequently needed to be surgically removed, was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, there was no evidence of device malfunction and the field reported that the "physician recognized that the patient's anatomy on the pulmonary artery side should have been considered more carefully prior to detachment of the ado from the delivery cable in order to avoid this incident.".
Event or Problem Description
On (b)(6) 2018, a 5/4 mm amplatzer duct occluder (ado) was selected for use.During the procedure, the ado was unable to be directed toward the pulmonary artery side when the ado deployed in and detached from the delivery cable at the patient's ductus.To replace the ado with a larger model 6/4 mm ado, the smaller ado was attempted to be removed from the ductus via a 9f amplatzer torqvue 45° exchange system (eitv) (model: 9-eitv09f45/80, lot: 5578020).As the patient's aorta was too thin due to down's syndrome, the ado was attempted to be retracted via a venous approach.The eitv delivery sheath was delivered through the pulmonary vein and the retraction of the ado continued.The large 9f sheath had been placed in the right ventricle and the patient developed an episode of pulmonary hypertension with a gradual decrease in blood pressure and required surgical intervention to remove the ado and surgically close the patient's ductus.There were no consequences to the patient reported and the patient is stable and has been discharged.The physician recognized that the patient's anatomy on the pulmonary artery side should have been considered more carefully prior to detachment of the ado from the delivery cable in order to avoid this incident.The ado was discarded at the hospital and will not be returned for analysis.The patient specific information of the patient identifier is not available for this case.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7817964
• Report Number: 2135147-2018-00118
• Device Sequence Number: 16755822
• Product Code: MAE
• UDI-Device Identifier: 00811806011103
• UDI-Public: 00811806011103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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: 07/31/2022
• Device Model Number: 9-PDA-003
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 6114135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/27/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 3 MO
• Patient Weight: 5