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)

Patient Problems Mitral Regurgitation (1964); Obstruction/Occlusion (2422)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned for evaluation.Conclusion: the causes of re-operation for failed repairs are well documented in the literature.Reoperations are primarily the result of a progression of disease or technical failures and not related to product malfunctions.Unlike bioprosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.This investigation found no intrinsic evidence to suggest a root cause related to manufacturing.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 approximately 2 years post implant of this annuloplasty ring, it was explanted and replaced with a bioprosthetic valve.Transesophageal echocardiogram (tee) revealed high velocity flow, increased gradients, central regurgant jet, and left ventricular outflow tract (lvot) obstruction.The patient experienced shortness of breath and fatigue.The annuloplasty ring was reported to be too small for the patient's anatomy.No further 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 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: 5752599
• MDR Text Key: 48271364
• Report Number: 2025587-2016-00938
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2017
• Device Model Number: 680R
• Device Catalogue Number: 680R24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2012
• 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: 74 YR