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

Model Number 900SFC26

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tricuspid Regurgitation (2112); No Code Available (3191)

Event Date 03/22/2018

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 from the patient that an unknown duration post implant of this tricuspid annuloplasty ring, the ring was repaired due to a leak.No additional adverse patient effects were reported. .

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 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: 7698716
• MDR Text Key: 114328322
• Report Number: 2025587-2018-01781
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169195349
• UDI-Public: 00643169195349
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: 900SFC26
• Device Catalogue Number: 900SFC26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 01/08/2018
• 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: 77 YR