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

Catalog Number UNK PORTICO

Device Problems Fracture (1260); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

The article, "computed tomography analysis of coronary chimney stenting following transcatheter aortic valve replacement", was reviewed.The article presented a retrospective, single center study to evaluate by a systematic analysis of post-tavr multi-slice computed tomography (msct) the anatomical features of coronary chimney stenting (chs) in transcatheter aortic valve replacement (tavr)-related coronary artery (ca) occlusion (cao).Devices included in this study were portico/navitor valve and evolut pro.The article concluded that msct findings after chs following tavr revealed the extremely complex relationship between ca stent and thv frame in the aortic root with potential implications in future coronary reaccess.Until long-term follow-up is available to determine the impact of late chs failure, this technique should be only considered in highly selected patients without other therapeutic options.The primary and corresponding author was (b)(6)].The time frame of the study was not provided.A total of 9 patients were included in the study, of which 8 (88.9%) received an abbott device.The average age was 81 years and the average gender was female.Comorbidities included coronary artery occlusion.

Manufacturer Narrative

Summarized patient outcomes/complications of post-tavr multi-slice computed tomography (msct) the anatomical features of coronary chimney stenting (chs) in transcatheter aortic valve replacement (tavr)-related coronary artery (ca) occlusion (cao) was reported in a research article "computed tomography analysis of coronary chimney stenting following transcatheter aortic valve replacement" in a subject population with multiple co-morbidities including coronary artery occlusion.Some of the complications reported were minor stroke, myocardial infarction, thrombosis, percutaneous angioplasty (unexpected medical intervention), thrombus, hypoattenuating leaflet thickening, stent fracture; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis literature attachment: article title " computed tomography analysis of coronary chimney stenting following transcatheter aortic valve replacement".

• Brand Name: PORTICO TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18595696
• MDR Text Key: 333967642
• Report Number: 2135147-2024-00389
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PORTICO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1