MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER II; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	9-PDA2-04-06
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 4/6mm amplatzer duct occluder ii and a 6mm amplatzer muscular vsd occluder were selected to close an aortic to right ventricular fistula.While attempting to deploy both devices, the physician reported that both devices were unstable.The case was aborted due to difficulty closing the defect.Additional information has been requested.
Additional Manufacturer Narrative
An event of "attempting to deploy the device but the device was unstable" was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported incident could not be conclusively determined.Please note per the instructions for use, document (b)(4) rev e , "the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus.".
Event or Problem Description
On (b)(6) 2019, a 4/6mm amplatzer duct occluder ii and a 6mm amplatzer muscular vsd occluder were selected to close an aortic to right ventricular fistula.While attempting to deploy both devices, the physician reported that both devices were unstable.The case was aborted due to difficulty closing the defect.Since no additional information has been provided, we will proceed with closure.If additional information becomes available, the file will be reopened.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8677033
• Report Number: 2135147-2019-00148
• Device Sequence Number: 3236364
• Product Code: MAE
• UDI-Device Identifier: 00811806011219
• UDI-Public: 00811806011219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 06/30/2021
• Device Model Number: 9-PDA2-04-06
• Device Catalogue Number: 9-PDA2-04-06
• Device Lot Number: 5559947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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