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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
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
(b)(4) - portico india, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 27mm portico valve was chosen for implant.Prior to procedure, the patient's platelet count was low, 58,000 - 60,000.During procedure, a pre-implant balloon aortic valvuloplasty (pre-bav) procedure was performed with an 22mm non-compliant non-abbott balloon.Rapid pacing at 180bpm was required during procedure.Post-deployment, it was noted the portico valve appeared a little constrained at the middle part.A decision was made to perform a post-bav with a 23mm non-complaint non-abbott balloon.Final implant depth was 6mm and there was no/trace aortic regurgitation and no paravalvular leak at end of procedure.Post-procedure on (b)(6) 2023 the platelet count reduced to 26,000 with no overt bleeding manifestations and anticoagulation was stopped.The patient's platelet count was closely monitored, however, there were no further drops in platelet counts and giant platelets were noted in peripheral smear.The patient was discharged in stable condition and their platelet count had increased to 48,000.It was reported the patient had a history of thrombocytopenia with giant platelets.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of valve underexpansion was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on all available information, a cause for the reported valve underexpansion could not be conclusively determined.It is possible that patient anatomy contributed to this event.However, this cannot be confirmed.The reported unexpected medical intervention was result of case-specific circumstances, as a post-implant valvuloplasty was performed.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 21294493
• Report Number: 2135147-2025-00508
• Device Sequence Number: 9199377
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: (01)05415067012494(17)240824(10)8136405
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 08/24/2024
• Device Catalogue Number: PRT-27
• Device Lot Number: 8136405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 73 KG