MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING TRI-AD 900SFC26; RING, ANNULOPLASTY

Model Number 900

Device Problem Leak/Splash (1354)

Patient Problems Jaundice (2187); Blood Loss (2597)

Event Date 10/25/2015

Event Type  Injury  

Manufacturer Narrative

Multiple attempts to obtain additional information have been unsuccessful.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information from the patient's family member that, approximately three months post implant of this tricuspid bioprosthetic ring, the patient underwent surgery to either repair or replace the patient's tricuspid valve, as the tricuspid valve had two leaks.The family member reported that the patient had been "losing blood" and appeared jaundiced.The family member could not confirm whether the bioprosthetic ring was removed or whether any new device was implanted.

Manufacturer Narrative

Device manufacturing date has been added to this report.

Manufacturer Narrative

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

• Brand Name: RING TRI-AD 900SFC26
• 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: 5257126
• MDR Text Key: 32366374
• Report Number: 2025587-2015-01253
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 900
• Device Catalogue Number: 900SFC26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2015
• 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: 00069 YR