MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 34MM; RING, ANNULOPLASTY

Model Number 690R34

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2018

Event Type  malfunction  

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 annuloplasty ring was implanted after the expiration date.No adverse patient effects were reported.

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 34MM
• 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: 7801233
• MDR Text Key: 117831284
• Report Number: 2025587-2018-02195
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169121713
• UDI-Public: 00643169121713
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K101212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2018
• Device Model Number: 690R34
• Device Catalogue Number: 690R34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2018
• Date Device Manufactured: 06/12/2013
• 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: 44 YR