MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION SIMULUS SEMI-RIGID ANNULOPASTY BAND; RING, ANNULOPLASTY

Model Number 800SC36

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

Patient Problem No Information (3190)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

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 this 36mm mitral annuloplasty band was implanted and explanted during the same procedure for unknown reasons.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the reason for immediate explant was that after fully suturing the band into place, it was determined to be too large.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9208403
• MDR Text Key: 163025935
• Report Number: 2025587-2019-03190
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169182141
• UDI-Public: 00643169182141
• Combination Product (y/n): N
• PMA/PMN Number: K083683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: 800SC36
• Device Catalogue Number: 800SC36
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR