MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 28MM; RING, ANNULOPLASTY

Model Number 680R

Device Problems Structural Problem (2506); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that immediately post implant of this annuloplasty ring in the mitral position, this device was explanted and replaced with a bioprosthetic tissue valve due to an unsuccessful repair, specifically, severing tethering of the leaflets.No other adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: RING PROFILE 3D 28MM
• 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: 5827749
• MDR Text Key: 50612546
• Report Number: 2025587-2016-01148
• Device Sequence Number: 1
• Product Code: KRH
• 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: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: 680R
• Device Catalogue Number: 680R28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2016
• 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: 77 YR
• Patient Weight: 45