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

Model Number	PRT-27
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/22/2023
Type of Reportable Event	Death
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 on (b)(6) 2023, a 27mm portico valve was selected for an implant.During the procedure the patient had annular rupture (slow leak).The cause of the annular rupture (slow leak) and treatment is unknown.The physician alleged that the annular rapture may had been cause by balloon aortic valvuloplasty (bav).The device was implanted successfully.The patient left the cath lab stable.The patient was transported back to the unit and was "hard to wake up from anesthesia.A cardiac computed tomography angiography (cta) of the head was performed and the patient crashed.Code blue was initiated and then patient passed on (b)(6) 2023.The cause of the death is annular rupture.The implanter classify this death as being related to the patient¿s comorbidities.
Additional Manufacturer Narrative
An event of annular rupture and patient death was reported.Information from the field indicated that the annular rupture may have been caused by balloon aortic valvuloplasty.Abbott has requested the procedure imaging and operative notes but was not provided by the field that the reported death was related to the patient's comorbidities, not due to the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications, including specification for radial force.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Based on the medical review" please note we do not have imaging or operative notes to inform this medical review.The patient had bav performed followed by implant of an navitor 27 mm device; post-procedure, while recovering the patient had cardiac arrest and expired.It was felt by the operators that the patient had an unrecognized annular rupture and this was the cause of the demise.It is unknown if echocardiography confirmed a pericardial fluid collection.At this time, the cause of death in undetermined.It is possible that the bav caused annular rupture as the physician noted."na.
Additional Manufacturer Narrative
An event of annular rupture and patient death was reported.Information from the field indicated that the annular rupture may have been caused by balloon aortic valvuloplasty.Abbott has requested the procedure imaging and operative notes but was not provided by the field that the reported death was related to the patient's comorbidities, not due to the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications, including specification for radial force.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Based on the medical review" please note we do not have imaging or operative notes to inform this medical review.The patient had bav performed followed by implant of an portico 27 mm device; post-procedure, while recovering the patient had cardiac arrest and expired.It was felt by the operators that the patient had an unrecognized annular rupture and this was the cause of the demise.It is unknown if echocardiography confirmed a pericardial fluid collection.At this time, the cause of death in undetermined.It is possible that the bav caused annular rupture as the physician noted.

• 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: 17339942
• Report Number: 2135147-2023-03066
• Device Sequence Number: 6912971
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2023

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: 05/08/2025
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Device Lot Number: 8495819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/23/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/07/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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: Death
• Patient Age: 80 YR
• Patient Sex: Female