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 Codes	Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)
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 a (b)(6) 2023, a 27mm portico valve was chosen for implant.The patient was considered high risk for surgery.The valve was successfully implanted.A post balloon aortic valvuloplasty (bav) was performed with a 22mm and a 24mm non-abbott balloon because there was a 22mmhg gradient post valve implant.It was suspected that the patient experienced possible coronary artery occlusion within seconds after the post-bav was performed.The patient's blood pressure dropped, and code blue medications were administered.On (b)(6) 2023, the patient died.It was confirmed that the native leaflet was sucked into the left coronary artery post bav, and the confirmed cause of death was coronary occlusion.
Additional Manufacturer Narrative
An event of hypotension, aortic valve stenosis, coronary artery occlusion, and patient death was reported.A more comprehensive assessment, including a histopathological examination of the valve tissue, could not be performed as the device was not returned for analysis.Based on the medical review, " the patient developed acute left coronary occlusion immediately after post-dilation of the navitor 27 mm valve, which led to cardiac arrest and death in the procedure room.The information provided states that the lca occlusion was confirmed, but it is not clear if this was confirmed by angiography or in another manner.Also, after reviewing the images and case narratives, i am not convinced that there was a coronary occlusion; i am suspicious that there was an annular rupture, given that the cv collapse occurred with seconds of the bav.Moreover, the contrast injections were such that the contrast did not enter the native sinus, thus, we can not determine if there was coronary flow.The coronary catheter, likewise did not enter the native sinuses." 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 root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on a (b)(6) 2023, a 27mm portico valve was chosen for implant.The patient was considered high risk for surgery.The valve was successfully implanted with the pre-release and final implant depth at 3mm on the non-coronary cusp and 5mm on the left coronary cusp.A 22mmhg gradient remained present post valve implant.A post balloon aortic valvuloplasty (bav) was performed with a 22mm and a 24mm non-abbott balloon to resolve the gradient.After the post-bav, the patient's blood pressure dropped, and it was suspected that the patient experienced possible coronary artery occlusion.The patient went into cardiac arrest and a code blue was called.Code blue medications were administered, and chest compressions were performed.On (b)(6) 2023, the patient passed away in the operating room.It was confirmed that the native leaflet was sucked into the left coronary artery post bav, and the confirmed cause of death was coronary occlusion.
Additional Manufacturer Narrative
An event of hypotension, aortic valve stenosis, coronary artery occlusion, and patient death was reported.A more comprehensive assessment, including a histopathological examination of the valve tissue, could not be performed as the device was not returned for analysis.Based on the medical review, "the patient developed acute left coronary occlusion immediately after post-dilation of the 27 mm portico valve, which led to cardiac arrest and death in the procedure room.The information provided states that the lca occlusion was confirmed, but it is not clear if this was confirmed by angiography or in another manner.Also, after reviewing the images and case narratives, there was no coronary occlusion; there might be an annular rupture, given that the cv collapse occurred within seconds of the bav.Moreover, the contrast injections were such that the contrast did not enter the native sinus.Thus, we can not determine if there was coronary flow.The coronary catheter, likewise, did not enter the native sinuses." the device history record was reviewed to ensure that each manufacturing and inspection.The operation was performed and the product met all specifications.Based on the available information, the root cause of the reported incident could not be conclusively determined.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: 17339955
• Report Number: 2135147-2023-03067
• Device Sequence Number: 15179151
• 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): 10/17/2023

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): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/27/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/25/2023; 10/17/2023
• 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: 81 YR
• Patient Sex: Female