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

Model Number 9-PDA-003

Device Problems Difficult to Insert (1316); Migration or Expulsion of Device (1395)

Patient Problems Embolism (1829); No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  Injury  

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 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.

Manufacturer Narrative

The report was submitted under the incorrect product code.The correct product code is mae.

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
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10339160
• MDR Text Key: 201016641
• Report Number: 2135147-2020-00333
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011103
• UDI-Public: 00811806011103
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention