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

Model Number	9-PDA2-06-06
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Embolus (1830)
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) 2020 a 6/4 amplatzer duct occluder ii (lot#6736010) was selected for implant in a (b)(6) year old male.During the procedure the device was determined to be too small and was removed from the patient and exchanged for a 6/6 amplatzer duct occluder ii (lot#7481147).The 6/6 amplatzer duct occluder ii was released from the delivery cable and seconds later the device embolized into the patient's ventricular outflow track.According to the physician this did not cause any patient issues.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.The following monday, the patient underwent elective mitral valve surgery.The embolized device was removed and the defect was surgically closed.The patient is currently stable.
Additional Manufacturer Narrative
The report was submitted under the incorrect product code.The correct product code is mae.
Additional Manufacturer Narrative
Additional information for: d7, g4, g7, h2, h3, h6, and h10.An event of amplatzer duct occluder ii embolization 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.The cause of the reported incident could not be conclusively determined.

• 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: 10376157
• Report Number: 2135147-2020-00353
• Device Sequence Number: 2849817
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: 00811806011264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2020

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: 03/31/2025
• Device Model Number: 9-PDA2-06-06
• Device Catalogue Number: 9-PDA2-06-06
• Device Lot Number: 7481147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 11/10/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/01/2020; 12/29/2020
• 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: 73 YR
• Patient Weight: 77