MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620RG31

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/11/2020

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 during the implant of this 31 mm mitral annuloplasty ring, it was explanted and replaced with a non medtronic product.The reason for the replacement was not reported.No additional adverse patient effects were reported.

• Brand Name: RING 620RG31 DURAN ANCORE ANNULOPLASTY C
• 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: 10462370
• MDR Text Key: 210464547
• Report Number: 2025587-2020-02690
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169793408
• UDI-Public: 00643169793408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2024
• Device Model Number: 620RG31
• Device Catalogue Number: 620RG31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/27/2020
• Date Device Manufactured: 08/29/2019
• 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: 74 YR