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

Model Number 620R

Device Problem Material Integrity Problem (2978)

Patient Problem Mitral Regurgitation (1964)

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 6: a (b)(6) year-old male with mitral valve prolapse had a 33-mm duran ring implanted 91 days prior to the mitral valve replacement.The patient required a mechanical valve implant due to leaflet repair breakdown and severe mitral regurgitation.At the time of the replacement, it was reported that the mitral annulus was dilated, the distance from the mitral annular region to the distal margin of anterior mitral leaflet was elongated, and fibrous tissue covered the ring.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: 5743471
• MDR Text Key: 47994062
• Report Number: 2025587-2016-00922
• 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: 43 YR