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

Catalog Number	PRT-27
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/29/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on 29 december 2023, a 27mm portico valve was chosen for implant using a large flexnav delivery system.The annular diameter of the native valve was 24mm, area was 434.4mm and perimeter was 75.3mm.A pre-dilatation was performed with a 20mm balloon and the patient went to cardiac arrest.It was necessary to release the under expanded valve.The initial implant depth was 8-9mm.During final deployment, there was tension in the delivery system and it was neutral.The final implant depth of the valve was 8-9mm.After the implant, it was noted that the valve embolized.The physician believed the cause of embolization was the under expanded valve and cardiopulmonary resuscitation (cpr) maneuvers.A new 27mm portico valve was chosen and a pre-dilatation was performed before to release the second valve.The valve was implanted under expanded.A post dilatation was performed in order to reduce under expansion of the second valve.After the implant of the second valve the patient continued in cardiac arrest.The patient passed away due to cardiac arrest.The physician mentioned the death was related to high risk procedure and patient´s comorbidities.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of valve underexpansion, migration, cardiac arrest and death was reported.Information from the field indicated that pre-dilatation was performed with a 20mm balloon and the patient went to cardiac arrest and that the valve was implanted at a depth of 8-9mm and that during final deployment, there was tension in the delivery system.A returned device assessment could not be performed as the device was not returned for analysis.However, imaging received from the field was reviewed and revealed that the valve (27 mm) was deployed and was severely constricted at the level of the annulus and embolized; cpr may have also contributed to the embolization.A second pre dilatation was performed and a second valve was deployed which also embolized.Based on the information received, the cause of the reported patient death could not be conclusively determined but could include acute lm occlusion, annular rupture, aortic injury (the crown of the valve was expanding the aorta significantly on imaging) and acute ai.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications, including specification for radial force.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note per the instructions for use, begin deploying the valve by turning the deployment/re-sheath wheel in the direction of the arrow on the handle.Allow the inflow edge4 of the valve to attain the target implant depth of 3 mm (0.12 in.) below the native aortic annulus.
Event or Problem Description
It was reported that on 29 december 2023, a 27mm portico valve was chosen for implant using a large flexnav delivery system.The annular diameter of the native valve was 24mm, area was 434.4mm and perimeter was 75.3mm.A pre-dilatation was performed with a 20mm balloon and the patient went to cardiac arrest.The left ventricular ejection fraction (lvef) was below to 20%.It was necessary to release the under expanded valve.The initial implant depth was 8-9mm.During final deployment, there was tension in the delivery system and it was neutral.The final implant depth of the valve was 8-9mm.After the implant, it was noted that the valve embolized.The physician believed the cause of embolization was the under expanded valve and cardiopulmonary resuscitation (cpr) maneuvers.A new 27mm portico valve was chosen and a pre-dilatation was performed before to release the second valve.The valve was implanted under expanded.A post dilatation was performed in order to reduce under expansion of the second valve.After the implant of the second valve the patient continued in cardiac arrest.The patient passed away due to cardiac arrest.The physician mentioned the death was related to high risk procedure and patient´s comorbidities.

• Brand Name: PORTICO TRANSCATHETER AORTIC VALVE
• 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: 18536931
• Report Number: 2135147-2024-00289
• Device Sequence Number: 7698055
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• 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: 2023
• 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): 03/05/2024

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: 05/02/2024
• Device Catalogue Number: PRT-27
• Device Lot Number: 9099221
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LARGE FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 81 KG