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

Model Number	PRT-23
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/31/2022
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 on (b)(6) 2022, a 23mm portico valve and a small flexnav delivery system were selected for procedure.The patient originally had a normal sinus rhythm.Prior to implant, a balloon aortic valvuloplasty (bav) was performed, and the patient experienced a heart block.The valve was successfully implanted, but the heart block continued to persist.A pacemaker was required to be implanted to treat the heart block.There was no clinically significant delay in procedure reported.The patient was stable and discharged at the time of report.
Additional Manufacturer Narrative
An event of heart block was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the available information, the root cause of the reported event could not be conclusively determined, but the 5mm depth of implant could have contributed to the heart block.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.H6.Previously reported medical device problem code has been replaced with 2616 malposition of device.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that there was minimal calcification beneath the aortic annular plane in the interventricular septum.The implant depth of the valve was 5mm.No additional information was provided.

• 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: 14838241
• Report Number: 2135147-2022-00446
• Device Sequence Number: 11358358
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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 Expiration Date: 04/18/2024
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 7960115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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(8311221)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 49 KG