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

Model Number	PRT-25
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/21/2022
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 25mm portico valve was selected for implant using a small flexnav delivery system.The femoral route was inaccessible; therefore the delivery point was the left subclavian artery.The valve was "difficult to be positioned with good annular alignment to the native aortic valve due to the steep aortic angulation (horizontal aorta)".At the 3rd deployment, the valve landed at an acceptable depth (4mm below the non-coronary cusp (ncc) and 9mm below the left coronary cusp (lcc).The valve self-centered and tilted clockwise after complete deployment, causing the lcc side to dive further down to the lvot (12mm below lcc).No transvalvular gradient was observed, however low aortic regurgitation (ar) index suggested moderate to severe aortic regurgitation.In addition, transesophageal echocardiogram (tee) and aortogram also suggested severe leakage over the lcc border of the valve.Balloon valvuloplasty was attempted with a 22mm balloon and then a 23mm balloon with no improvement.The physician elected to implant a second valve.A new 25mm portico valve was prepared and successfully implanted with no complications.The second valve was released at 1mm below ncc and 4mm below lcc.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of moderate to severe aortic regurgitation, severe leakage was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "prior to release, position the fluoro source to ensure the struts at the distal (lvot) portion of the valve are aligned and confirm the depth of the implant is approximately 3mm.".
Event or Problem Description
Subsequent to the previously filed report, additional information was received that small felxnav delivery systems were used to implant the two 25mm portico valves.The 25mm portico valves were sized using multi-slice computed tomography (msct) measurements.The valve-in-valve procedure was not considered an emergency to prevent permanent impairment or death, but rather to optimize the treatment outcome.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.It was noted that the first 25mm portico valve tilted and migrated toward the left ventricular outflow tract (lvot) over the side of the left coronary cusp after complete deployment.It was noted that the trace aortic regurgitation after a successful valve-in-valve procedure was considered acceptable and required no further intervention/treatment.The patient was stable at the time of reported.The cause of the first 25mm portico valve's migration was deemed to be from access through the left subclavian and the increased aortic angulation (horizontal aorta) making the valve positioning more challenging and thereby resulted in valve migration.

• 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: 16153584
• Report Number: 2135147-2023-00190
• Device Sequence Number: 12611530
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2025
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 8496152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 58 KG