MAUDE Adverse Event Report: HEART VALVES SANTA ANA SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

Model Number 800

Device Problem Incomplete Coaptation (2507)

Patient Problems Failure of Implant (1924); Mitral Regurgitation (1964)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that immediately post implant of this annuloplasty ring in the mitral position, this ring was explanted and replaced with a bioprosthetic valve due to excessive regurgitation of the patient's native valve, and posterior leaflet flail.The physician reported that the patient's "native mitral annulus was small," and they were "unable to achieve a satisfactory repair" using several different techniques.Following implant of this ring and synthetic mitral valve chordae, the "valve was a bit more competent, but there was very little plane of coaptation.The anterior leaflet was completely extended." following placement of additional synthetic mitral valve chordae, "the valve was not sufficiently competent.And the annuloplasty ring began to separate from the anterior portion of the annulus." at this point, mitral valve repair was abandoned and a bioprosthetic mitral valve was implanted.No other adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 6055640
• MDR Text Key: 58353104
• Report Number: 2025587-2016-01672
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

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 Expiration Date: 01/31/2021
• Device Model Number: 800
• Device Catalogue Number: 800SR26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: 10/06/2016
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2016
• 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: 68 YR
• Patient Weight: 72