MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620R27 DURAN ANCORE ANNULOPLASTY 27; RING, ANNULOPLASTY

Model Number 620R27

Device Problem Incomplete Coaptation (2507)

Patient Problems Host-Tissue Reaction (1297); Mitral Valve Stenosis (1965)

Event Date 03/01/2009

Event Type  Injury  

Manufacturer Narrative

Citation: yunoki j.J card surg 2009;24:143-145.Mitral valve stenosis caused by abnormal pannus extension over the prosthetic ring and leaflets after duran ring mitral annuloplasty date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.

Event Description

Medtronic received information via literature of a (b)(6) year-old female patient with for non-rheumatic mitral regurgitation (mr) associated with a ruptured posterior leaflet chordae.She underwent a procedure with quadrangular resection, reconstruction of the posterior leaflet chordae, and implant of a 27-mm medtronic duran ring.Subsequently, five years and eight months (at the age of (b)(6) years) after the initial implant the patient presented with exertional dyspnea.Radiography showed mild cardiac enlargement.Electrocardiogram revealed sinus rhythm with left atrial overload.Cardiac catheterization showed pulmonary artery pressure of 60/35.During a sternotomy the mitral ring and both leaflets were found covered by pannus which narrowed the mitral orifice and restricted the leaflet mobility.The ring and both leaflets were resected.Histopathological examination showed foreign body granuloma associated with giant cells around the excised duran ring and leaflet thickening together with infiltration of inflammatory cells.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING 620R27 DURAN ANCORE ANNULOPLASTY 27
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5887172
• MDR Text Key: 52488558
• Report Number: 2025587-2016-01282
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 620R27
• Device Catalogue Number: 620R27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 61 YR