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

Model Number	9-ATV10F45/80
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
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
It was reported a 24mm amplatzer septal occluder was chosen for procedure.During procedure, after several attempts at positioning the device (the device was re-sheathed 4 times), the device disconnected from the delivery cable (in the absence of the necessary maneuvers for release).The device migrated into the left ventricle.Attempts were made to recapture device in the cath lab but were unsuccessful.The stable patient was transferred to a different hospital for surgical removal of the device and surgical repair of the defect.Although the patient remained stable throughout the procedure, the event did cause a prolonged hospitalization, a stay in the intensive care and mechanical ventilation.The patient has since been discharged.No additional information has been provided.Related manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
An event of the device disconnecting from the cable after several attempts at repositioning the device was reported.A more comprehensive 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.

• 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: 13085749
• Report Number: 2135147-2021-00589
• Device Sequence Number: 5319836
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: 05415067030948
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 03/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 9-ATV10F45/80
• Device Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 7707486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 12/26/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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: 24MM AMPLATZER SEPTAL OCCLUDER.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown