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

Model Number PRT-27

Device Problems Difficult to Fold, Unfold or Collapse (1254); Central Regurgitation (4068)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6)2022, a 27mm portico valve was selected for implantation.Pre-procedure imaging assessment confirmed that the patient had a bicuspid aortic valve with severe calcification.A pre-balloon valvuloplasty was done with a 22mm non-abbott balloon.The 27mm portico valve was loaded into a large flexnav delivery system.Due to the severe uneven calcification, it was difficult to position the valve at an optimal depth.The valve was finally deployed at 4mm below the non-coronary cusp, and 8mm below the left-coronary cusp.After deployment, the valve then tilted, and migrated to 4mm below non-coronary cusp, and 12mm below left coronary cusp.A aortogram showed that there was severe aortic regurgitation, with the catheter based hemodynamic measurements suggested a low ar index and residual transaortic gradient around 60mmhg.A balloon valvuloplasty was conducted with the same 22mm non-abbott balloon.The aortic regurgitation persisted.It was decided to implant another 27mm portico valve, in a valve in valve procedure.The second 27mm portico valve was deployed using a large flexnav delivery system.The valve was deployed at 2mm below the non-coronary cusp and 4mm below the left coronary cusp.The valve did not expand fully, and balloon valvuloplasty was performed with another 22mm non-abbott balloon.The final hemodynamic measurements suggested minimal ar with stable blood pressure and an acceptable transaortic gradient.The annular perimeter was noted as 80.4mm.The patient was reported to be stable.No additional information was reported.

Manufacturer Narrative

An event of valve migration, severe aortic regurgitation 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 defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note that per the instructions for use, "prior to release, use appropriate imaging to ensure the struts at the inflow (lvot) portion of the valve are aligned and confirm the depth of the implant is approximately 3 mm (0.12 in.)."h1: report type corrected to serious injury.

• Brand Name: PORTICO
• Type of Device: 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: 15834206
• MDR Text Key: 307481814
• Report Number: 2135147-2022-02127
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Device Lot Number: 8328603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 58 KG