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

Model Number	PRT-29
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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 on (b)(6) 2022, a 29mm portico valve was selected for implant using a large flexnav delivery system.The patient's perimeter was determined to be 79.1mm via computed tomography (ct) scan and the valve was sized according to the ifu.It was noted during procedure that the valve was too proximal during an initial deployment attempt.An attempt was made to res-sheath the valve.However, it was noted that the portico valve was unable to be recaptured.There were multiple attempts made to try fully recapture the portico valve back into the delivery system, but the valve for remained 40% deployed.It was observed via angiography that the delivery system was kinked.The decision was made to implant the 29mm portico valve in the descending aorta because it was the safest place to release without causing any damage.The delivery system was removed, and it was discovered that the valve capsule of the large flexnav delivery system was damaged.A second 29mm portico valve (18832400) was implanted in a valve in valve procedure with a replacement large flexnav delivery system.The patient remained hemodynamically stable throughout the procedure.The patient was in recovery at the time of the report.
Additional Manufacturer Narrative
An event of valve being too proximal during deployment was reported.It was also reported that the valve was deployed in the descending aorta as it was the safest place to release without causing any damage.A returned device assessment could not be performed as the device remains 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 defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Subsequent to the previously fled report, additional information was received: it was reported that the patient did not have a tortuous anatomy.The patient's annular perimeter was 79.1mm and the portico valve had been sized using a computed tomography scan and according to the instruction for use (ifu).There was no initial or prolonged hospitalization as a result of this event.It is unknown what caused the damage to the valve capsule of the large flexnav delivery system.No additional information was provided.

• 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: 15849666
• Report Number: 2135147-2022-02174
• Device Sequence Number: 17443781
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/11/2023

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: 11/09/2022
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 7753798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown