MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS FLEXIBLE BAND; RING, ANNULOPLASTY

Model Number 700FC

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

Patient Problem No Code Available (3191)

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.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 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 10: a (b)(6) male with systemic hypertension and secondary functional mitral regurgitation was implanted with a 38-mm simulus semi-rigid band.One year post-implant, the patient was noted with a dehisced ring, leaflet repair breakdown, and restricted posterior mitral leaflet.A mechanical valve was implanted.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: SIMULUS FLEXIBLE BAND
• 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: 5743480
• MDR Text Key: 47993810
• Report Number: 2025587-2016-00924
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052899
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700FC
• Device Catalogue Number: 700FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: 05/26/2016
• Supplement Dates FDA Received: 09/23/2017
• 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: 62 YR