MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING; RING, ANNULOPLASTY

Model Number 620R

Device Problems Partial Blockage (1065); Gradient Increase (1270); Reflux within Device (1522); Material Separation (1562)

Patient Problems Pulmonary Dysfunction (2019); Tricuspid Valve Stenosis (2113); High Pulmonary Arterial Wedge Pressure (2480); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Citation: moaz-metzl d., et al.Transcatheter tricuspid valve replacement in dehisced flexible ring.Catheter cardiovasc interv.2021 apr 1; 97(5):e739-e742.Doi: 10.1002/ccd.29162.Pmid: 32761862.Epub 2020 aug 6.Earliest date of publish used for date of event.Medtronic products referenced: duran ancore ring (pma# k960356, product code: krh).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.

Event Description

Medtronic received information via literature regarding a (b)(6) year-old female patient with morbid obesity, chronic obstructive pulmonary disease (copd) and child-pugh class b cirrhosis who had previously undergone surgical mitral valve repair using a 25-mm medtronic duran ancore annuloplasty ring and surgical tricuspid valve repair using a 27-mm medtronic duran ancore annuloplasty ring 13 years prior (unique device identifier numbers not provided).The patient was hospitalized with worsening heart failure where an echocardiogram revealed severe tricuspid mixed stenosis/regurgitation with elevated transvalvular pressure gradients, severe right ventricular dilatation with severe hypokinesis and severe pulmonary hypertension.Heart catheterization demonstrated elevated pulmonary vascular pressure and elevated left atrial pressure.A chest computerized tomography (ct) demonstrated septal dehiscence of the duran ring.The patient underwent transcatheter tricuspid in-valve replacement with a 29-mm non-medtronic valve.A three-month follow-up demonstrated significant improvement in symptoms and tricuspid valve function by echocardiography.No additional adverse patient effects or product performance issues were reported.

• Brand Name: DURAN ANCORE RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12314477
• MDR Text Key: 266255130
• Report Number: 2025587-2021-02538
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 620R
• Device Catalogue Number: 620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2021
• 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
• Treatment: DURAN MITRAL ANNULOPLASTY RING
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR