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

Model Number	PRT-23
Medical Device Problem Codes	Calcified (1077); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/12/2022
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
It was reported that in 2013, a 78 year old patient with history of severe aortic stenosis had a 23mm portico valve successfully implanted.The patients annulus had a coronary height of 7-8mm and a very slim sinotubular junction.On (b)(6) 2022, the patient returned and the decision was made to explant the portico valve because of aortic stenosis.A valve-in-valve procedure was not feasible due to anatomical risks and extreme risk of coronary obstruction.The portico valve was successfully explanted and replaced with a 19mm non-abbott device.The patient was doing well at the time of report.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the 23mm portico valve had been implanted in the patient on (b)(6) 2013.It was also noted that the patient had a history of right ventricular systolic dysfunction with a usual pulmonary arterial pressure of 28mmhg.The 23mm had been sized using a combination of computed tomography imaging and heart navigator.A pre-implant baseline balloon aortic valvuloplasty (bav) had been performed prior to implant of the 23mm portico valve.On (b)(6) 2022, mild aortic regurgitation had also been noted via transthoracic echocardiography (tte) examination.It was noted during the explant procedure that structural valve deterioration had occurred due to build up of calcification and pannus on the valve.After successful replacement of the portico valve only a mild paravalvular leak was noted in the patient.The patient was discharged and in good condition at the time of report.
Additional Manufacturer Narrative
An event of explant of the valve after 9 years due to regurgitation was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.Information from the field indicated that the valve had a buildup of calcification and pannus present on the valve, which could have contributed to the reported regurgitation.There is no indication of a product quality issue with regards to manufacture, design, or labeling.D6: implant date corrected.

• Brand Name: PORTICO
• 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: 15196137
• Report Number: 2135147-2022-00705
• Device Sequence Number: 2162247
• 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: 2013
• Device Explanted Year: 2022
• 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): 11/23/2022

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 Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Unknown