MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING TRI-AD 900SFC32; RING, ANNULOPLASTY

Model Number 900

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

Patient Problem No Information (3190)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested, but no new information has been received to date.The device has not been received for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that immediately following implant of this annuloplasty ring in the tricuspid position, this ring was explanted and replaced with a smaller sized ring.No failure mode and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this ring was explanted because the surgeon was not satisfied with the repair, believing that the chosen ring was of the incorrect size.No significant regurgitation was noticed while testing the valve after the ring was placed, however the surgeon was not satisfied with valve coaptation, so smaller size was used.There were no other adverse effects to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING TRI-AD 900SFC32
• 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: 6137357
• MDR Text Key: 61185740
• Report Number: 2025587-2016-01887
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093903
• 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,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 900
• Device Catalogue Number: 900SFC32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2015
• 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: 23 YR