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

Catalog Number UNK NAVITOR

Device Problem Off-Label Use (1494)

Patient Problems Anemia (1706); Dyspnea (1816); Hemolysis (1886); Perforation (2001); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/02/2024

Event Type  Injury  

Event Description

The article, "an unusual complication after transcatheter aortic valve implantation: a case report", was reviewed.The article presented a case study of an 80-year-old female patient with two prior surgical aortic valve replacement procedures, one unknown valve in 2002 that required reintervention in 2012 for aortic stenosis and replaced with a 19mm mitroflow.It was reported that on an unknown date in september 2021, a 23mm navitor valve was chosen for an off-label transcatheter valve-in-valve (viv) procedure due to severe aortic regurgitation and decompensated heart failure along with concomitant chimney stenting of both coronary arteries.After the navitor valve was implanted, it was noted there was high residual gradient (30mmhg) and a decision was made to perform a post-dilation with balloon aortic valvuloplasty (post-bav) with a non-compliant balloon.The first post-bav attempt was insufficient so another post-bav attempt was made with a high-pressure non-compliant balloon to fracture the mitroflow valve ring.The second attempt resolved the gradient but the balloon ruptured, resulting in a small shunt between the left and right side.Transthoracic echocardiography (tte) confirmed an iatrogenic ventricular septal defect (vsd) sized 6x4mm.The patient experienced a new holosystolic murmur with a preserved second sound without heart failure.During hospital admission, it was reported the patient experienced third-degree atrioventricular block and required a permanent pacemaker.The patient was discharged 4 days after procedure.It was then reported on an unknown date during a follow-up, the patient developed severe hemolytic anemia and required blood transfusions.The patient then experienced heart failure again with dyspnea at rest, for which she was readmitted to the hospital.It was reported on an unknown date in october 2021, a 6mm amplatzer muscular vsd occluder was chosen for implant to close the iatrogenic vsd.After the device was released, it was noted there was a persistent residual shunt but the result was acceptable and the physician decided to end the procedure and wait for proper endothelization.The article concluded that a viable alternative to redo surgery is viv tavi.Risks include higher rates of prosthesis¿patient mismatch and coronary obstruction.Occasionally, bioprosthetic valve fracture is required, particularly in small bioprostheses, to achieve low gradients.Anecdotally, fracture has led to annular rupture and vsd.Most vsds are small and without clinical or hemodynamic repercussions; however, in symptomatic cases, percutaneous closure is a viable alternative to surgery.[the primary and corresponding author was alba abril molina, university hospital juan ramón jiménez, ronda norte, s/n, 21005 huelva, spain, with corresponding email: aabrilmo@gmail.Com].

Manufacturer Narrative

Literature review: "an unusual complication after transcatheter aortic valve implantation: a case report" b3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided as reported in a research article, " an unusual complication after transcatheter aortic valve implantation: a case report", on an unknown date in september 2021, a 23mm navitor valve was chosen for an off-label transcatheter valve-in-valve (viv) procedure due to severe aortic regurgitation and decompensated heart failure along with concomitant chimney stenting of both coronary arteries in an 80-year-old female patient with two prior surgical aortic valve replacement procedures, one unknown valve in 2002 that required reintervention in 2012 for aortic stenosis and replaced with a 19mm mitroflow.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.Peri- and post-procedural complications included perforation, unexpected medical intervention, heart block, hemolytic anemia (hemolysis and anemia), heart failure, hospitalization, surgical intervention, off-label use, dyspnea.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note per the instructions for use, the navitor¿ valve is designed to be implanted in the native calcific aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve.

• Brand Name: NAVITOR 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): 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: 18791510
• MDR Text Key: 336393301
• Report Number: 2135147-2024-00879
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK NAVITOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female