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

Model Number	PRT-23
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Heart Block (4444); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
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
Crd_1025 - portico valve-in-valve retrospective registry, patient site id: eu0119 - 75, r727408201, r727412001, r727410501.It was reported that on (b)(6) 2021, a 23mm navitor valve was selected for implantation using a small flexnav delivery system into a patient with a past medical history of anemia and 2nd degree heart block.During the procedure, after the valve was implanted, a grade 3 paravalvular leak was found by echocardiogram.Balloon valvuloplasty was attempted twice without success.A second 23mm navitor valve was then implanted and the leak was resolved.On (b)(6) 2021, the patient was transfused packed red blood cells.No overt bleeding during procedure was noted.On (b)(6) 2021 the patient was diagnosed with third degree complete heart block and had a permanent pacemaker implanted.The patient had a prolonged stay at the hospital for monitoring of the rhythm.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of heart block and loss of blood due to multiple tavi procedures was reported.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 specifications.Heart block is a well recognized complication of transcatheter aortic valve implantation procedures associated with known risk factors including, patient age, pre-existing heart block, or anatomical factors such as calcification extending beneath aortic annular plane in the interventricular septum.Information from the field indicated that there was not calcification extending beneath aortic annular plane in the interventricular septum and that the patient had a history of heart block, which could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - clinical code: code 4582 removed.H6 medical device problem code: code 1457 removed.

• 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: 16108211
• Report Number: 2135147-2023-00049
• Device Sequence Number: 20721018
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 03/22/2024
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 7923224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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 DELIVERY SYSTEM, FNAV-DS-SM, 7940480
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG