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

Model Number	PRT-29
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature article: valve embolization during transcatheter aortic valve implantation: incidence, risk factors and follow-up by computed tomography investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The article, ¿valve embolization during transcatheter aortic valve implantation: incidence, risk factors and follow-up by computed tomography¿, was reviewed.This research article aimed of this study was to analyze the incidence of transcatheter valve embolization and migration (tvem) in a large cohort of patients undergoing transcatheter aortic valve implantation (tavi) and to examine embolized valves by computed tomography (ct) late after tavi.This research article reported a case study 77-year-old female patient that had a 29mm portico valve implanted.The valve was pulled into the ascending aorta due to incomplete release from the delivery catheter.The final transcatheter heart valve position was noted to be in the ascending aorta.A valve-in-valve was performed using a 26mm sapien 3.At 43 months follow up computerized tomography (ct) scan revealed upper crown protruding into the aortic wall.The article concluded tvem represents a rare complication of tavi.Follow up-ct detected no pathological findings req spontaneous embolization into aorta, migration into left ventricle, incomplete release from delivery catheter, embolization during post dilatation, loss of capture during implantation.During intervention.[the primary and corresponding author of this article henryk dreger, md, 1 medizinische klinik mit schwerpunkt kardiologie und angiologie, charité ¿ universitätsmedizin berlin, berlin, germany].
Additional Manufacturer Narrative
As reported through a literature article, ¿valve embolization during transcatheter aortic valve implantation: incidence, risk factors and follow-up by computed tomography¿, a (b)(6) patient that had a 29mm portico valve implanted.The valve was pulled into the ascending aorta due to incomplete release from the delivery catheter.The final transcatheter heart valve position was noted to be in the ascending aorta.A valve-in-valve was performed using a 26mm sapien 3.At 43 months follow up computerized tomography (ct) scan revealed upper crown protruding into the aortic wall.The article concluded tvem represents a rare complication of tavi.Follow up-ct detected no pathological findings require spontaneous embolization into aorta, migration into left ventricle, incomplete release from delivery catheter, embolization during post dilatation, loss of capture during implantation requiring intervention.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PORTICO TRANSCATHETER AORTIC VALVE
• 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: 17326684
• Report Number: 2135147-2023-03037
• Device Sequence Number: 15117891
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 11/30/2024
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 Age: 77 YR
• Patient Sex: Female