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

Model Number	PRT-29
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Embolism/Embolus (4438); Insufficient Information (4580)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 29 mm portico valve was selected for implant with a flexnav delivery system.After deployment of the valve in the aortic annulus and before the delivery catheter was removed from the annulus, the valve migrated up towards the aorta.The patient was sent to surgery to explant the valve.A 25 mm non-abbott valve was then implanted.The patient status was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of the valve migrating after deployment, and blocking the coronary arteries was reported.The valve was returned to abbott for analysis and was found to have broken wires consistent with explant from the patient the device history record was reviewed to ensure that each manufacturing and inspection operation was performed including the valve meeting stent radial force specifications, and the product met all specifications.Based on the information received the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 health effect - clinical code: code 4580 removed.
Event or Problem Description
It was reported that on (b)(6) 2022, a 29mm portico valve was selected for implant with a flexnav delivery system.After deployment of the valve in the aortic annulus and before the delivery catheter was removed from the annulus, the valve migrated up towards the aorta.The patient was sent to surgery to explant the valve.A 25mm non-abbott valve was then implanted.The patient status was reported as stable.Subsequent to the previously filed report, additional information was received that the aortic annular dimensions were 24mm by 28mm.For the valve that migrated, the starting implant depth at deployent was 8mm.The final implant depth at release was 8mm.There was sufficient calcium to allow anchoring of the device in the opinion of the user.There was no tension in the delivery system at the time of final deployment.The patient did not have a horizontal aorta.The migrated valve blocked a coronary artery.The patient experienced hypotension.The valve was removed via open heart surgery.

• 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: 15420502
• Report Number: 2135147-2022-01204
• Device Sequence Number: 6722274
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 12/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2024
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8034217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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: FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG, LOT 8338110; PORTICO VALVE, PRT-29, LOT 8034217, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male