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	Arrhythmia (1721); Cardiac Arrest (1762)
Date of Event	08/24/2022
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
This event is being conservatively reported as the cause of the patient¿s death was due to perforation caused by non-abbott devices (ptfe guidewire and al-1 catheter).It was reported that on (b)(6) 2022, during the procedure a non-abbott catheter (al-1 catheter) was initially found to be in a bad position.A pigtail catheter was used to reposition the guidewire.Delivery of the 23mm portico valve was attempted 3 times and the valve was fully recaptured to reposition for optimal depth.There was some difficulty with maintaining optimal position of the portico valve due to mild calcification and arrhythmia, the patient was placed on a temporary pacemaker at 120 beats per minute, which helped successfully implant the valve.Aortography was performed and there was minimal aortic insufficiency that decreased after a few minutes.At the time of release the patient fell into cardiac arrest and resuscitation maneuvers were performed.The patient had become hypotensive despite medication and resuscitation measures.The patient was stabilized and the cause was reported to be pericardial effusion with tamponade due to posterior perforation as seen by transthoracic echocardiogram.Attempt to drain the pericardial effusion was unsuccessful and the patient was sent to surgery.A thoracotomy was performed, attempts to close the perforation was done using a patch.Due to capillary fragility the bleeding could not be controlled.The patient was proclaimed deceased.The patient was treated with multiple medications, direct cardiac massage, various blood products.It was thought that the perforation was due to the crossing of the native valve with the non-abbott catheter (al-1 catheter) at the time of non-abbott guidewire (ptfe guidewire) exchange.The cause of death was noted as hemorrhagic hypovolemic shock due to the perforation.That patient's condition prior to the procedure was reported as very fragile, high risk for surgery and critical aortic stenosis.
Additional Manufacturer Narrative
An event of cardiac perforation and patient death due to hemorrhagic hypovolemic shock due perforation during the portico valve implant procedure was reported.It was also reported that the patient had high fragility prior to the procedure.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 perforation was thought to be caused by the non-abbot catheter and guidewire during crossing of the native valve at the time of the guidewire exchange.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: 15473923
• Report Number: 2135147-2022-01333
• Device Sequence Number: 4323053
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 12/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 8527669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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: FLEXNAV DELIVERY SYSTEM SM, FNAV-DS-SM, LOT8311221.; FLEXNAV LOADING SYSTEM SM, FNAV-LS-SM, LOT 8219874.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown