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

Model Number H608H

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Heart Failure (2206)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that 16 years 10 months post implant of this mitral annuloplasty ring, the patient presented with persistent hypotension and acute chronic congestive heart failure with worsening symptoms including shortness of breath and fatigue.A transesophageal echocardiogram (tee) showed severe mitral stenosis and severe mitral insufficiency.The physician stated that the annuloplasty ring appeared to be overly small, and the regurgitation appeared to be due to tethering of the posterior and anterior leaflets.The physician explanted the device, performed a debridement of the mitral valve from an investing scar, and implanted a 27mm annuloplasty band.No evidence of mitral regurgitation or mitral stenosis was observed post implant.No further adverse patient effects were reported.

Manufacturer Narrative

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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5463126
• MDR Text Key: 39117528
• Report Number: 2025587-2016-00238
• 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,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2004
• Device Model Number: H608H
• Device Catalogue Number: H608H29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/1999
• 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: 00070 YR
• Patient Weight: 93