MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN TISSUE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK TISSUE HEART VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Cardiac Tamponade (2226)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Literature article: mini-aortic valve replacement versus transcatheter aortic valve implantation: a propensity-matched study.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effect of malfunction reported in the article is captured under a separate medwatch report.It was reported that 1613 patients were included in this study between january 2015 and december 2021, and 176 patients were implanted using an epic biocor procedure with an average age of 71.7.Summarized patient outcomes/complications of piccolo were reported in a research article in a subject population with multiple co-morbidities, chronic obstructive pulmonary disease, diabetes, asthma, prior cerebrovascular accident, prior percutaneous coronary intervention, and on hemodialysis.Some of the complications reported were paravalvular regurgitation (paravalvular leak), permanent pacemaker (surgical intervention, cerebrovascular accident (stroke), new renal replacement therapy (renal failure), cardiac tamponade, and bleeding.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.

Event Description

The article, ¿mini-aortic valve replacement versus transcatheter aortic valve implantation: a propensity-matched study¿, was reviewed.The article presented a retrospective, multi-center experience to compare the outcomes of patients with aortic stenosis treated with minimally invasive approaches: mini-sternotomy for aortic valve replacement (mini-avr) and transcatheter aortic valve implantation (tavi) implantation.Tavi devices included were evolut r-78 (30.6%), evolut pro-60 (23.5%), sapien 3/ultra-102 (40%), direct flow-2 (0.8%), corevalve-3 (1.2%), sapien xt-5 (2%), sapien-1 (0.4%), 1 (0.4%) with lotus, 2 (0.8%) with portico, and 1 (0.4%) with accurate neo valves.Avr patients were treated predominantly with perceval 37 (26.2%), and trifecta 51 (36.2%), 7 (5%) with st jude, 17 (12.1%) with carpentier, 6 (4.3%) with on-x, 10 (7.1%) with ats, 9 (6.4%) with crown, 3 (2.1%) with mitroqow, and 1 with other mechanical valve manufacturer.The article concluded for eligible aortic stenosis patients in the 7th decade of life, mini-avr remains an excellent therapeutic option.[(b)(6)].The time frame of the study was between january 2015 and december 2021.A total number of 1613 patients were included in this study (tavi=1437; mini-avr=176).The average age was 81 years (tavi=82.2; mini-avr=71.7) and the average gender was male (tavi=51%; mini-avr=48.9%).Comorbidities included chronic obstructive pulmonary disease, diabetes, asthma, prior cerebrovascular accident, prior percutaneous coronary intervention, on hemodialysis.

• Brand Name: UNKNOWN TISSUE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 17626983
• MDR Text Key: 321992269
• Report Number: 2135147-2023-03735
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• 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
• Patient Outcome(s): Disability; Life Threatening; Required Intervention