MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 24MM; RING, ANNULOPLASTY

Model Number 680R

Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); No Information (3190)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

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 1 year 2 months post implant of this mitral annuloplasty ring, the device was explanted and replaced with a bioprosthetic valve for unknown reasons.No other adverse patient effects were reported.

Manufacturer Narrative

Additional information received indicated that the device was explanted due to symptomatic mitral stenosis, residual regurgitation, and elevated gradients.The physician stated that the ring was probably too small for the patient, and this, combined with underlying subvalvular fibrosis, led to the stenosis.No additional adverse patient effects were reported. added patient weight; added patient device codes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING PROFILE 3D 24MM
• 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: 6770935
• MDR Text Key: 81942870
• Report Number: 2025587-2017-01317
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759269
• UDI-Public: 00613994759269
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2020
• Device Model Number: 680R
• Device Catalogue Number: 680R24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2015
• 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: 63