MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

Model Number 800SR28

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Regurgitation (1964); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

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 immediately after implanting this 28mm annuloplasty ring in the mitral position, the ring was explanted and replaced with a 31mm bioprosthetic valve.The physician indicated the valve could not be repaired and had to be replaced.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the repair was not sufficient due to severe residual regurgitation, caused by the severity of the patient's valvular disease.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.

Manufacturer Narrative

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

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY 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: 7672079
• MDR Text Key: 113498495
• Report Number: 2025587-2018-01695
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169182226
• UDI-Public: 00643169182226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072655
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 800SR28
• Device Catalogue Number: 800SR28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 06/25/2017
• 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: 58 YR