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

Model Number	PRT-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/23/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2022, a 23mm portico valve was selected for implant using a small flexnav delivery system.It was noted that a pre-implant dilatation was performed using an unknown 20mm balloon catheter.It was also noted that during procedure the valve had to be re-sheathed due to be deployed too deep.It was noted during a second deployment attempt, that the patient's blood pressure dropped when the 23mm portico valve was 80% deployed.The decision was made to fully deployed/release the valve, but the patient's blood pressure remained low.The patient was administered unknown drugs and given a cardiac massage in an attempt to mitigate their low blood pressure, but was deemed ineffective.An angiogram was performed and discovered a pericardial effusion.The decision was made to perform a pericardiocentesis.A few minutes after the pericardiocentesis the patient passed away.The cause of the patient's drop in blood pressure, pericardial effusion and death are unknown.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of cardiac tamponade and patient death was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the patient was not in a good condition prior to the procedure.It was also indicated that the patient had extensive calcifications of the anulus which was thought to be the cause of the cardiac tamponade.It was believed that patient's drop in blood pressure and death was due to the ventriculo-aortic junction dissection.The event was thought to be caused by patients anatomical features and medical history.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was reported that prior to implanting the 23mm portico valve, the patient had a pulmonary edema and was not in a good condition.The patient's activated clotting time was 270 seconds and heparin was administered.The patient was administered adrenalin and noradrenalin and given a cardiac massage in an attempt to mitigate their low blood pressure, but was deemed ineffective.The pericardial effusion was found by echocardiogram and angiogram, and then the pericardial effusion escalated into a cardiac tamponade.It is believed that the extensive calcifications of the anulus is the cause of the cardiac tamponade.It is believed that the cause of the patient's drop in blood pressure, and death is the ventriculo-aortic junction dissection.It is believed that the event is caused by patients anatomical features and medical history.There was no clinically significant delay in procedure.
Additional Manufacturer Narrative
An event of cardiac tamponade and patient death was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the patient was not in a good condition prior to the procedure.It was also indicated that the patient had extensive calcifications of the anulus which was thought to be the cause of the cardiac tamponade.The likely cause of the death was annular rupture from balloon pre-dilation (a compliant balloon was used) which caused acute pericardial tamponade.The event was thought to be caused by patients anatomical features and medical history and was unrelated to the navitor implant.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15965197
• Report Number: 2135147-2022-02510
• Device Sequence Number: 5574404
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 03/30/2023

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: 06/13/2024
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 8040689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 03/16/2023; 03/28/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 03/20/2023; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SMALL FLEXNAV DELIVERY SYSTEM. FNAV-DS-SM(8409496)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown