MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG35 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, a definitive conclusion cannot be made regarding the clinical observation.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 immediately following implant of this annuloplasty band, it was explanted and replaced with a bioprosthetic valve due to systolic anterior motion (sam).Echocardiogram revealed moderate mitral regurgitation prior to replacement.No other adverse patient effects were reported.

Manufacturer Narrative

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.

• Brand Name: RING 620RG35 DURAN ANCORE ANNULOPLASTY C
• 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: 6556298
• MDR Text Key: 74789361
• Report Number: 2025587-2017-00771
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759160
• UDI-Public: 00613994759160
• 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
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2021
• Device Model Number: 620B
• Device Catalogue Number: 620BG35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: 04/18/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2016
• 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: 56 YR
• Patient Weight: 79