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

Model Number 9-PDA-006

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

On (b)(6) 2019, 5mm amplatzer duct occluder was selected for use and positioned at the patient's defect, but deemed unsuitable due to size, so the device was re-sheathed and removed.A 6mm amplatzer duct occluder was then selected for implant.After the 6mm device was re-positioned three times, on the third attempt, the device released from the cable prematurely and embolized.The device was snared via the femoral artery and the patient is reported to be discharged.Additional information has been requested.

Event Description

On (b)(6) 2019, 8/6 amplatzer duct occluder (pda) was selected for use and positioned at the patient's defect, but deemed unsuitable due to size, so the device was resheathed and removed.Another 10/8 pda and delivery sheath were selected for implant.After the pda was re-positioned three times, on the third attempt, the device prematurely released from the cable and embolized.The device was snared via the femoral artery and the defect was then successfully closed with a 6/7 mvsd.The patient is reported to be discharged.

Manufacturer Narrative

An event of premature release and 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 at the time of commercialization.The cause of the reported incident could not be conclusively determined.According to instructions for use, 600207-008 revision b " do not release the amplatzer duct occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable.Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace with a new device".

• 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
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8369565
• MDR Text Key: 137118257
• Report Number: 2135147-2019-00048
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: 00811806011134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 9-PDA-006
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 6379627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/18/2019; 04/05/2019
• Supplement Dates FDA Received: 03/18/2019; 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention