MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number 638BL34

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 34mm mitral annuloplasty band, the band was explanted and replaced with a 32mm annuloplasty band of the same model.The reason for replacement was not reported.No additional adverse patient effects were reported. .

• Brand Name: CG FUTURE BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 9363204
• MDR Text Key: 167609399
• Report Number: 2025587-2019-03556
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169793620
• UDI-Public: 00643169793620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052860
• 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
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: 638BL34
• Device Catalogue Number: 638BL34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Date Device Manufactured: 06/29/2018
• 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: 56 YR