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

Model Number	9-ATV07F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 6mm by 4mm amplatzer duct occluder was chosen for implant using a 7f amplatzer trevisio delivery system.The purpose of the procedure was closure of a gerbode defect.The physician attempted to place the rail guidewire and loader through the delivery system but there was difficulty getting the loader to fit along the wire.The wire was removed and the occluder was advanced through the delivery system without issues.At the end of the procedure, a full echocardiogram (echo) assessment was performed and showed what they thought was a loose chordae tendineae.It was unknown if the chordae tendineae were damaged by either abbott device.The overall function of the mitral valve remained unchanged from the begging of the case to the end of the procedure.The patient remained hemodynamically stable throughout the procedure.The patient was reported as doing well.
Event or Problem Description
It was reported that on (b)(6) 2023, a 6mm by 4mm amplatzer duct occluder was chosen for implant using a 7f amplatzer trevisio delivery system.The purpose of the procedure was closure of a gerbode defect.The defect was accessed via the femoral artery.The physician attempted to place the rail guidewire and loader through the delivery system but there was difficulty getting the loader to fit along the wire.The wire was removed and the occluder was advanced through the delivery system without issues.The occluder and delivery system were advanced from the right jugular vein to the left ventricular out flow tract (lvot).Initial placement of the distal end of the occluder was established from the lvot.At the end of the procedure, a full echocardiogram (echo) assessment was performed and showed what appeared to be loose chordae tendineae.It was unknown if the chordae tendineae were damaged by either abbott device.The overall function of the mitral valve remained unchanged from the beginning of the case to the end of the procedure.The patient remained hemodynamically stable throughout the procedure.The patient was reported as doing well and discharged.
Additional Manufacturer Narrative
An event of damaged chordae tendineae was reported.A returned device assessment could not be performed as the device was not returned for analysis.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17168195
• Report Number: 2135147-2023-02685
• Device Sequence Number: 7065560
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• UDI-Public: 05415067030900
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 04/30/2025
• Device Model Number: 9-ATV07F45/80
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 8476330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female