MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 28MM; RING, ANNULOPLASTY

Model Number 680R

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); No Information (3190)

Event Date 09/18/2017

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 this 28 mm mitral annuloplasty ring was implanted and explanted during the same procedure and replaced with a 27 mm mitral bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this 28mm mitral annuloplasty ring was implanted and explanted during the same procedure.The physician stated that it was not used due to the patients native tissue had annular calcification.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 28MM
• 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: 7045931
• MDR Text Key: 92528133
• Report Number: 2025587-2017-02209
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759245
• UDI-Public: 00613994759245
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 680R
• Device Catalogue Number: 680R28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Date Device Manufactured: 03/01/2017
• 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: 73 YR
• Patient Weight: 57