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

Model Number	PRT-27
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
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) 2023, a 27mm portico valve was implanted.Post-implant with adequate height, "the valve smoothly migrated to the aorta." there was no issue with the large flexnav delivery system.The migration of the 27mm portico valve had been confirmed using echocardiography and fluoroscopy.The valve was sized using computed tomography scans.The final implant depth of the 27mm portico valve was 3mm, as recommended per the instructions for use.It was noted that there was sufficient calcium to allow anchoring of the device.The patient did not have horizontal aorta and there had been no difficulty implanting the valve.The migrated valve did not block any coronary arteries.No damaged was reported to the patient.A new 27mm portico valve was successfully implanted.It was also noted that a post-implant dilatation was performed after the implant of the second 27mm portico valve.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.There was no allegation of malfunction against the 27mm portico valve, large flexnav delivery system or procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of valve migration after deployment 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 that the product met all specifications.Information from the field indicated that the final implant depth of the valve was 3mm.The field also indicated that there was no difficulties in deploying, or retracting valve during the procedure and that there was sufficient calcium to allow anchoring of the device in the opinion of the user.Additional information indicated the valve was sized through angio ct.There was no allegation against the abbott device.Based on the information received, the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 16233259
• Report Number: 2135147-2023-00269
• Device Sequence Number: 6972885
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/17/2023

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: 09/20/2024
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Device Lot Number: 8246287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown