MAUDE Adverse Event Report: HEART VALVES SANTA ANA RING PROFILE 3D 30MM; RING, ANNULOPLASTY

Model Number 680R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for analysis.Without the return 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 device was replaced with a bioprosthetic valve due to regurgitation following the repair.No other adverse patient effects were reported.

Manufacturer Narrative

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.

• Brand Name: RING PROFILE 3D 30MM
• 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: 6382995
• MDR Text Key: 69202364
• Report Number: 2025587-2017-00355
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759238
• UDI-Public: 00613994759238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073324
• 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: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Model Number: 680R
• Device Catalogue Number: 680R30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2015
• 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: 75 YR
• Patient Weight: 122