MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG35 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620BG35

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/29/2019

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 mitral annuloplasty band, it was explanted.The reason for explant and the replacement product were not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that this 35mm annuloplasty band was replaced with a 31mm annuloplasty ring.The reason for replacement was not available.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: RING 620RG35 DURAN ANCORE ANNULOPLASTY C
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8321199
• MDR Text Key: 135547205
• Report Number: 2025587-2019-00541
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169793491
• UDI-Public: 00643169793491
• Combination Product (y/n): N
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: 620BG35
• Device Catalogue Number: 620BG35
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 99