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

Model Number	PRT-23
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 2135147-2023-02309.Clinical information: crd_1025 - portico valve-in-valve retrospective registry, patient site id: (b)(6) (r753412201, r753414101).It was reported that on (b)(6) 2021, a 23mm portico valve was implanted via a valve-in-valve procedure.The previously implanted valve was a 19mm trifecta valve with aortic stenosis.On (b)(6) 2022, the patient had a stroke.Symptoms included left arm weakness.The national institute of health stroke scale (nihss) score was 2.Patient was provided physical and occupational therapy exercises.On (b)(6) 2022, the patient was discharged.On (b)(6) 2022, the patient had a stroke with nihss score of 1.On (b)(6) 2022, the magnetic resonance imaging (mri) of the head/brain indicated a stroke.Patient was provided with physical and occupational therapy.On (b)(6) 2022, the patient was discharged.No additional information was provided.
Additional Manufacturer Narrative
Related manufacturer report number: 2135147-2023-02309.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: (b)(6) - portico valve-in-valve retrospective registry, patient site id: (b)(6).Subsequent to the previously filed report, additional information was received that the most patient symptoms resolved within days or weeks of onset, but apraxia of fingers is still persistent.In june 2023, a computed tomography (ct) scan was performed, and valve had thrombosis present.Hypoattenuated leaflet thickening (halt) was also observed, which was accentuated on non-coronary cusp (ncc) and right coronary cusp (rcc), along with reduced leaflet motion of ncc and rcc, grade 2 insufficiency.No additional information was provided.
Additional Manufacturer Narrative
An event of stroke, thrombus and hypoattenuated leaflet thickening (halt) was reported.Information from the field indicated that the site believed the stroke was related to the presence of valve thrombosis.A returned device assessment could not be performed as the device 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, including specifications for radial force.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 2993 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: 16998732
• Report Number: 2135147-2023-02310
• Device Sequence Number: 20495332
• 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): 07/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 7267600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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: Hospitalization; Disability
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 64 KG