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

Model Number 620R

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Medtronic received information via literature study regarding the immediate and midterm outcomes of non medtronic percutaneous transvenous transcatheter mitral valve, that had been implanted into a failed surgical bioprosthetic mitral valve or mitral ring.All data was collected from multiple centers from january 2014 to december 2015.The study population included 48 patients (predominately female, mean age 76 ± 11 years) that were implanted with a non-medtronic transvenous transcatheter mitral valve.However, it was reported that the non-medtronic product had been implanted into 12 mosaic valves, 8 medtronic hancock valves and 1 duran ring (serial numbers not provided).No deaths were attributed to a medtronic device.Among the patient with a previously implanted duran ring, adverse events included; stenosis, mild regurgitation and calcification, treated with the implant of a non-medtronic device.No adverse patient effects were reported.

Manufacturer Narrative

(added patient code (b)(4) to this report as a duplicate code (b)(4) had been inadvertently added.To the previous report.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.

Manufacturer Narrative

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

• Brand Name: DURAN ANCORE RING
• 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: 6239517
• MDR Text Key: 64422377
• Report Number: 2025587-2017-00069
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960356
• 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: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 620R
• Device Catalogue Number: 620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 76 YR