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

Catalog Number	PRT-27
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Codes	Vascular Dissection (3160); Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/22/2024
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
Crd_1024 - portico india.In4509 - 27 (r834632101,r83529850).It was reported that on (b)(6) 2024, 27mm portico valve was selected for implant.The sizing of the annular dimensions of the native valve was: perimeter derived diameter 23.8, area 441.5 mmsq, perimeter 74.8 mm.There was sufficient calcium to allow anchoring of the device in the opinion of the user.The patient presented with severe asymptomatic aortic stenosis with heart failure, new york heart association class iv.He was managed initially with non-invasive ventilation and intravenous diuretics.The device was implanted in the patient with a final depth of 0mm.A subtle distal migration towards aortic side was noted post deployment resulting in moderate aortic regurgitation., implanter snared the valve up to the ascending aorta with the snare above the coronaries and the physician aware of the ifu warning against snaring the valve.There was a valve in valve procedure was performed with a new 27mm portico valve.Post deployment of the second valve, there was no leak or any significant gradient across the valve.On the same day, the patient post procedure ekg showed left bundle branch block.A 3 days holter test was done.On (b)(6) 2024, a permanent pacemaker was implanted due to left bundle branch block with mobitz type 2 atrioventricular block.The patient is stable.
Additional Manufacturer Narrative
An event of device migration, device malposition, heart block, aortic valve insufficiency/regurgitation, and improper or incorrect procedure or method was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that the device was implanted in the patient with a final depth of 0mm (shallower than the recommended 3mm).The patient presented with severe asymptomatic aortic stenosis with heart failure.The valve migrated toward aortic side which resulted in moderate aortic regurgitation.The implanter snared the valve up to the ascending aorta with the snare above the coronaries and the physician aware of the ifu warning against snaring the valve.There was a valve in valve procedure was performed with a new portico valve.There was sufficient calcium to allow anchoring of the device.A permanent pacemaker was implanted due to left bundle branch block with mobitz type 2 atrioventricular block.Based on all available information, the reported device malposition is due to procedural conditions.A cause for the reported device migration could not be conclusively determined.A cause for the reported aortic valve insufficiency/regurgitation appears to be related to device migration.The reported heart block could not be conclusively determined.The reported improper or incorrect procedure or method is related to the user snaring the device after deployment.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 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: 19090364
• Report Number: 2135147-2024-01659
• Device Sequence Number: 7216146
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 04/06/2024
• Device Catalogue Number: PRT-27
• Device Lot Number: 7966421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 48 KG