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	12/14/2022
Type of Reportable Event	Malfunction
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 27mm portico valve was selected for implant.During procedure, the valve migrated above the annulus.The patient was reported to be in stable condition.No additional information was reported.
Additional Manufacturer Narrative
An event of the valve migrating after implant was reported.A returned device assessment and histopathological examination 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.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, annular calcium distribution, deployment or retraction difficulties.Information from field indicated that the implant depth at release was about 1mm above annulus and the implant depth at deployment was 1-2mm below annulus.The field reported that there was sufficient calcium to allow anchoring of the device and there was no tension in the delivery system at the time of final deployment.Additional information from the field indicated that a post- dilatation was done during the procedure which was believed to be the cause of the reported migration.Based on the information received, the cause of the reported incident could not be conclusively determined but could have been as a result of the combination of valve implant depth or post dilatation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note per 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 3mm" also, "to minimize likelihood of permanent pacemaker implantation (ppi): a) maintain implant depth of 3mm, and b) limit manipulations across the lvot".
Event or Problem Description
It was reported that on (b)(6) 2022, a 27mm portico valve was selected for implant.During procedure, the valve migrated above the annulus.Subsequent to the previously filed report, additional information was received.The patient did not have a horizontal aorta.The size of the annular dimensions were 76.6mm.The implant depth at deployment was 1-2mm below the annulus.Upon release, the implant depth was approximately 1mm above the annulus.The portico valve did not block a coronary artery/arteries.No tension was in the delivery system at the time of final deployment and there was no interaction between the delivery system and the portico valve.Of note, post-dilatation was performed and it is alleged that the migration was due to the post-dilatation.The patient did not experience a hypertensive spike or pulmonary hypertension at the time of migration.The portico was not attempted to be snared.A new non-abbott valve was successfully implanted via valve-in-valve.No patient consequences were reported.

• 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: 16118070
• Report Number: 2135147-2023-00094
• Device Sequence Number: 6961319
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2025
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Device Lot Number: 8462789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: 83 YR
• Patient Sex: Female