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

Model Number 620R

Device Problems Detachment Of Device Component (1104); Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

Title: assessment of mitral annuloplasty ring by cardiac computed tomography: correlation with echocardiographic parameters and comparison between two different ring types citation: the journal of thoracic and cardiovascular surgery 2015 volume 150(5):1082-90 (doi 10.1016/j.Jtcvs.2015.07.019) authors: young joo suh, md, byung-chul chang, md, phd, dong jin im, md, yun jung kim, md, yoo jin hong, md, geu-ru hong, md, phd, and young jin kim, md, phd month and year of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review regarding the assessment of mitral annuloplasty rings by cardiac computed tomography.All data were collected from a single center between january 1995 and august 2005.The retrospective study population included 45 patients (predominantly male; mean age 57.2 years), 18 of which were implanted with medtronic duran mitral annuloplasty ring (serial numbers not provided).Among all patients with this mitral annuloplasty ring, adverse events included: 1 incident of severe paravalvular leak (pvl), 18 incidents of pannus, 9 incidents of stenosis and subsequent increased gradient measurements (> 5 mm hg).Three re-operations were reported one due to stenosis, and two re-operations due to detachment of the ring.No additional adverse patient effects were reported.

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: 5810497
• MDR Text Key: 50058447
• Report Number: 2025587-2016-01107
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K960356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• 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: 06/22/2016
• 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: 57 YR