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

Model Number	PRT-27
Medical Device Problem Codes	Perivalvular Leak (1457); Malposition of Device (2616)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: crd_699 - portico ide, patient site id:(b)(6).Although a death occurred, this report is for the moderate paravalvular aortic regurgitation.It was noted that this was also present post implant.The cause of death was unknown but the physician did not classify the cause of the patient's death as being related to the performance of the device.It was reported that on (b)(6) 2019, a 27mm portico valve was successfully implanted in patient.There was no post-implant balloon aortic valvuloplasty (bav) performed.The patient was stable prior to procedure.Post procedure day one on (b)(6) 2019, it was noted that there was moderate paravalvular leak on the echocardiogram.The final implant depth of the valve was 1mm.It was noted that within the last year the patient was doing well with no issue with pain, palpitations, or breathlessness.On an unknown day in (b)(6) 2022, the patient was evaluated and an echocardiogram revealed that the patient's left ejection fraction had improved from 35% to 50%, with only abnormal wall motions noted.It was also noted that there was moderate paravalvular aortic regurgitation present.It was unknown if there were any intervention performed for the moderate paravalvular aortic regurgitation.On (b)(6) 2022, the patient passed away.The cause of death is currently unknown, the patient passed away at home.The physician does not classify the cause of the patient's death as being related to the performance of the implanted device,.There were no allegations of malfunction against the 27mm portico valve.No additional information was provided.
Event or Problem Description
Clinical information: (b)(6) - portico ide, patient site id: (b)(6).Although a death occurred, this report is for the moderate paravalvular aortic regurgitation.It was noted that this was also present post implant.The cause of death was unknown but the physician did not classify the cause of the patient's death as being related to the performance of the device.It was reported that on (b)(6) 2019, a 27mm portico valve was successfully implanted in patient.There was no post-implant balloon aortic valvuloplasty (bav) performed.The patient was stable prior to procedure.Post procedure day one on (b)(6) 2019, it was noted that there was moderate paravalvular leak on the echocardiogram.The final implant depth of the valve was 1mm.It was noted that within the last year the patient was doing well with no issue with pain, palpitations, or breathlessness.On an unknown day in (b)(6) 2022, the patient was evaluated and an echocardiogram revealed that the patient's left ejection fraction had improved from 35% to 50%, with only abnormal wall motions noted.It was unknown if there were any intervention performed for the moderate paravalvular aortic regurgitation.On (b)(6) 2022, the patient passed away.The cause of death is currently unknown, the patient passed away at home.The physician does not classify the cause of the patient's death as being related to the performance of the implanted device.There were no allegations of malfunction against the 27mm portico valve.
Additional Manufacturer Narrative
An event of moderate paravalvular aortic regurgitation was reported.A returned device assessment could not be performed as the device remained implanted was not returned for analysis.The field indicated that there were no allegations of malfunction against the abbott device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the available information, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 health effect - clinical code: code 4450 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: 16492434
• Report Number: 2135147-2023-01029
• Device Sequence Number: 6536361
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2019
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Device Lot Number: 6140004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White