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

Model Number	9-PDA-003
Medical Device Problem Codes	Difficult to Insert (1316); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Embolism (1829); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
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, an amplatzer duct occluder (9-pda-003) was selected for implant in the patient using a 5f amplatzer torqvue delivery system.During the procedure, the delivery system was inserted into the patient, but it was impossible to advance the amplatzer duct occluder onto the delivery system.There was resistance felt at the connection with the loading tube and the initial part of the delivery system.The physician decided to exchange the delivery system for a 6f amplatzer torqvue delivery system.There was no resistance felt and the amplatzer duct occluder was successfully implanted in the patient with no significant delay in the procedure.A few seconds after the device was placed in the patient, the device embolized to the left iliac artery of the patient.The device was snared through a 10f introducer with no patient complications.Immediately after the device was removed, the physician implanted a larger amplatzer duct occluder (9-pda-005) with the 6f amplatzer torqvue delivery system with no complications.The patient experienced no serious injuries and is currently discharged.
Additional Manufacturer Narrative
The report was submitted under the incorrect product code.The correct product code is mae.
Additional Manufacturer Narrative
An event of difficulty advancing the occluder through the sheath and device embolization was reported.The investigation confirmed the device met dimensional and functional 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 event could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10339160
• Report Number: 2135147-2020-00333
• Device Sequence Number: 11475480
• Product Code: MAE
• UDI-Device Identifier: 00811806011103
• UDI-Public: 00811806011103
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Replace
• 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: 08/31/2022
• Device Model Number: 9-PDA-003
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 6146233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 10/20/2020; 11/10/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/23/2020; 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