MAUDE Adverse Event Report: ABBOTT MEDICAL PORTICO; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	PRT-27
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
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
This report is for the initial 27mm portico valve that migrated requiring a valve-in-valve.It was reported that on (b)(6) 2022, a 27mm portico valve was chosen for implant using a large flexnav delivery system.During the procedure, the valve was implanted at the intended depth with about 4mm in the outflow tract.After the valve was fully released, it embolized through the aorta and stopped at the aortic arch.It was determined the embolized device had not caused damage and would not cause damage to the patient's health and it was decided that it would remain implanted.Then, a second 27mm portico valve was then successfully implanted.Afterwards, the patient's blood pressure dropped and remained low for 10 minutes.The patient then went into cardiogenic shock and their heart stopped.A 180v shock was delivered and the patient was stabilized.The patient then left the surgical center and went under observation in the intensive care unit (icu).Four hours post-surgery, the patient was reported as stable and reacting well to stimulus.The following morning, on (b)(6) 2022, the patient went into cardiac arrest and died.There was no interaction between the delivery system and the 1st implanted portico valve.It was noted that the implant procedure, patient's age and anatomy contributed to this event.Related manufacturer reference number: 2135147-2022-02467-00.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device embolized through the aorta and stopped at the aortic arch was reported.A returned device assessment could not be performed as the device remained implanted and 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 reported incident could not be conclusively determined.

• Brand Name: PORTICO
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15982536
• Report Number: 2135147-2022-02550
• Device Sequence Number: 15177088
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2024
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Device Lot Number: 8246287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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: FLEXNAV DS, FNAV-DS-LG, 8382912.; LARGE FLEXNAV DS, FNAV-DS-LG, 8391219.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown