MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 26MM; RING, ANNULOPLASTY

Model Number 680R26

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: 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 post implant of this 26mm mitral annuloplasty ring, the ring was explanted and replaced with a 24mm ring of the same model.The reason for the replacement was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information was received that the 26mm annuloplasty ring was replaced due to a sizing error.The 24mm ring was used and successfully repaired the native mitral valve.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING PROFILE 3D 26MM
• 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: 8145249
• MDR Text Key: 129746729
• Report Number: 2025587-2018-03350
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759252
• UDI-Public: 00613994759252
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073324
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: 680R26
• Device Catalogue Number: 680R26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2018
• Date Device Manufactured: 02/23/2018
• 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: 38 YR