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

Model Number	9-ATV09F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	05/04/2022
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 25mm amplatzer pfo occluder was implanted on (b)(6) 2022.On (b)(6) 2022, it was noted that the patient had been experiencing numbness and tingling on upper thigh.A duplex ultrasound was done and the patient was admitted into the hospital.Vascular surgeon performed another ultrasound and it confirmed a 1cm pseudoaneurysm.Surgical intervention was not needed.Patient stable.
Additional Manufacturer Narrative
An event of pseudoaneurysm was reported.Information from field indicated that the patient did not had difficult anatomy and there were no difficulties implanting the device.The patient¿s monitored activated clotting time was within the recommended range for the procedure.Abbott requested for procedure imaging to review, this was not provided by the site.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that activated coagulation time prior to the procedure was 303 seconds.There was no difficulty with arduous anatomy or any difficult anatomy.The patient tolerated the procedure well with no complications.The cause of the pseudoaneurysm was unknown.No additional information was provided.

• Brand Name: AMPLATZER TREVISIO
• 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: 14903388
• Report Number: 2135147-2022-00468
• Device Sequence Number: 14999436
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: 05415067030931
• Combination Product (Y/N): N
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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 Model Number: 9-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White