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

Model Number PRT-27

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 27mm portico valve was chosen for implant using a large flexnav delivery system.The valve was sized as 77.4mm.During the procedure, valve was implanted at the recommended depth of 3mm on the non-coronary cusp.However, the operator misjudged the implantation process and the released the valve before having full annular contact.The valve reportedly migrated to -2mm, in the sinus.The valve was snared into the ascending aorta to stabilize it before performing a valve in valve procedure.An additional 27mm portico valve (19351309) was then implanted at 5mm.A mild leak was detected, and the gradient was measured at 4 mmhg.A post-dilatation was performed because of the leak.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in the procedure.The patient was reported as discharged.

Manufacturer Narrative

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

Manufacturer Narrative

An event of valve migration after deployment was reported.A returned device assessment could not be performed as the device 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.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, annular calcium distribution and deployment or retraction difficulties.Information from field indicated that there was sufficient calcium to allow anchoring of the device.However, the operator misjudged the implantation process and released the valve before having full annular contact causing the valve to migrate.Additional information indicated that the valve was snared and a valve in valve procedure was performed.Based on the information received, the reported incident is consistent with the valve being released in an undesirable position.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, "once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.".

• 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: 15936636
• MDR Text Key: 305046493
• Report Number: 2135147-2022-02371
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• 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: 8444454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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: 79 YR
• Patient Sex: Male