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

Model Number DUCT OCCLUDER II

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, a 5mm x 6mm amplatzer duct occluder ii successfully implanted for a mitral paravalvular leak, next to an implanted mechanical mitral valve.The valve model and make unknown and was implanted some time in 2021.On (b)(6) 2022, it was reported that the patient was experience some hemolysis the implanted device.The patient was experiencing fatigue increased to a point beyond what the patient was experiencing prior to placement of the occluder.Black, bloody urine as well.A recent transesophageal echocardiogram (tee) was performed and it appeared flow was coming through the device when the proximal disk would open during the cardiac cycle.The physician and patient reviewing options to have the device removed or another device placed.In november on an unknown date, the patient was seen by a hematologist who referred back to implanting physician once hemolysis was suspected and receives weekly blood transfusions.Patient is on anticoagulant regime due to prior mechanical valves in both aortic and mitral positions implanted at different times.Patient is stable, no additional information was provided.

Manufacturer Narrative

An event of hemolysis about two months after the implant procedure, flow coming through the device and the device being used off-label was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that there was flow coming through the device when the proximal disk would open during the cardiac cycle.The implant of the device in a location different from the intended defect could have contributed to the event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note, per the instructions for use, " the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus."h6: medical device code 4001 (patient device interaction problem) removed.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16134473
• MDR Text Key: 307062964
• Report Number: 2135147-2023-00158
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011240
• UDI-Public: 00811806011240
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: DUCT OCCLUDER II
• Device Catalogue Number: 9-PDA2-05-06
• Device Lot Number: 6363288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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
• Patient Age: 69 YR
• Patient Sex: Male