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

Model Number 620R

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problems Mitral Regurgitation (1964); Hemolytic Anemia (2279)

Event Date 03/19/2016

Event Type  Injury  

Manufacturer Narrative

Citation: roberts w et al.Mitral valve replacement after failed mitral ring insertion with or without leaflet/chordal repair for pure mitral regurgitation.Am j cardiol.2016 jun 1;117(11):1790-807.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 regarding unfortunate consequences of mitral valve repair with ring or band implantation.The study population included 29 patients (predominantly male; mean age 61 years), four of which were implanted with medtronic duran ring and one of which was implanted with medtronic ats simulus semi-rigid band.The serial numbers were not provided.Patient 7: a (b)(6) male with mitral valve prolapse and systemic hypertension was implanted with a 33-mm duran ring.At 161 days post-implant, the patient had severe mitral regurgitation and hemolysis which required a blood transfusion.A coronary artery bypass graft (cabg) procedure was performed, the ring explanted and a mechanical valve was implanted.The explanted ring was noted as dehisced with prolapse of the anterior mitral leaflet and was covered in fibrous tissue.No additional adverse patient effects were reported regarding medtronic product.

Manufacturer Narrative

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

• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5743474
• MDR Text Key: 47995002
• Report Number: 2025587-2016-00923
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960356
• 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,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 620R
• Device Catalogue Number: 620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 69 YR