MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ATV09F45/80
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturing reference number: 2135147-2021-00320.It was reported that an 18mm amplatzer septal occluder was selected for implant in the patient on (b)(6) 2021.The patient was prescribed the anticoagulant heparin and was reported to be in compliance with the medication.The physician performed the procedure step by step and used a 9f amplatzer¿ trevisio¿ intravascular delivery system together with a 002 amplatzer guidewire.The system was introduced into the patient and at the moment of positioning the sheath to release the prosthesis, it was noted when analyzing the echocardiogram and scopy images that there was a thrombus.The entire system was removed from the patient and it was verified that there was a thrombus through the system.The physician replaced the delivery system with a 10f amplatzer¿ trevisio¿ intravascular delivery system, replaced the guidewire with another 002 amplatzer guidewire and selected a 19mm amplatzer septal occluder for implant.The 19mm amplatzer septal occluder was placed without complication until the end of the procedure in hemodynamics.There is no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
An event of thrombus was reported.A more comprehensive assessment could not be performed, as the device was not returned for analysis.However, images were received for analysis.Based solely on the aforementioned photos, there appeared to be blood on the delivery system.The device history record was reviewed, to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
An event of thrombus was reported.The investigation confirmed that the device was received at abbott with staining consistent with exposure to blood on the delivery cable.Photos received from the field also appeared to show blood on the device.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¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12319621
• Report Number: 2135147-2021-00321
• Device Sequence Number: 4454837
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: 05415067030931
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2022

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: 09/30/2023
• Device Model Number: 9-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 7687341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 01/18/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/27/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9-ASD-018
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown