MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA SJM TISSUE HEART VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Obstruction of Flow (2423)

Patient Problem Heart Block (4444)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "transcatheter valve-in-valve-in-valve replacement in tricuspid position in a patient with pre-existing permanent dual-chamber", was reviewed this research article reports a redo transcatheter valve-in-valve-in-valve procedure in a patient with a dysfunctional transcatheter valve-in-valve prosthesis(edwards sapien 3, 29 mm) in a prior surgically implanted prosthesis(st.Jude medical, 31 mm) in tricuspid position.A (b)(6) patient with a complex past medical history including multiple open-heart surgeries presented with severe dyspnea and recurrent syncope.The patient had a history of intravenous drug abuse with recurrent infective tricuspid valve endocarditis.Additional diagnoses included hepatitis c and chronic obstructive pulmonary disease.In 2011 recurrent tricuspid valve endocarditis required surgical valve replacement with implantation of a 31mm sjm bioprosthesis valve, followed shortly afterwards by the implantation of a dual-chamber pacemaker due to complete heart block with the ventricular lead positioned through the prosthesis.In 2017 a first transcatheter valve-in-valve replacement (edwards sapien 3) was performed due to structural degeneration of the implanted valve, thereby trapping the ventricular pacemaker lead between the sapien and the surgically implanted sjm prosthesis.At time of presentation, echocardiography showed relevant stenosis (peak/mean gradient 12.7/5.5 mmhg) and a mild regurgitation of the sapien prosthesis.The physician opted to implant another sapien 3 valve.The postprocedural course was uneventful with a definite decline in symptoms and discharge in improved clinical condition 7 day post procedure.The article concluded that valve-in-valve-in-valve replacement in tricuspid valve position is a feasible and safe alternative to delay or avoid redo surgery in patients with failing transcatheter implanted valve-in-valve prostheses.The primary and correspondence author of the article is philipp lake, department of internal medicine iii, university hospital of cologne, kerpener strasse 62, 50937 cologne, germany with the corresponding email:philipp.Lake@uk-koeln.De.

Manufacturer Narrative

As reported in a research article, a valve-in-valve to replace the implanted tissue valve trapped an implanted pacemaker lead between the two valves.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: SJM TISSUE HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 11979967
• MDR Text Key: 267134976
• Report Number: 3001883144-2021-00085
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR