MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION DURAN ANCORE; RING, ANNULOPLASTY

Model Number H601

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Regurgitation (2259); No Information (3190)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 20 years 8 months post implant of this mitral annuloplasty ring was explanted and replaced with bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Medtronic received additional information that the reason for explant of this ring was due to severe mitral regurgitation.Once the device was replaced with a bioprosthetic valve post surgery transesophageal echocardiogram (tee) noted satisfactory mitral valvular function with no paravalvular leak (pvl) or regurgitation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DURAN ANCORE
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7045244
• MDR Text Key: 92508019
• Report Number: 2025587-2017-02197
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• 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,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2001
• Device Model Number: H601
• Device Catalogue Number: H601H31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Date Device Manufactured: 05/15/1996
• 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: 51 YR
• Patient Weight: 128