MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 28MM; RING, ANNULOPLASTY

Model Number 690R

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that during implant of this 28mm annuloplasty ring in the tricuspid position and after the ring had been sutured into place, the physician noted that the patient's tricuspid valve was leaking.The physician determined that a smaller size annuloplasty ring would be more appropriate for the patient.The device was explanted and replaced with a 26mm annuloplasty ring successfully.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the user facility disposed of the product specimen.Conclusion: surgeons often attempt to repair valves in lieu of replacing them due to improved long-term clinical outcomes.There are occurrences when a valve repair is attempted using a repair device and subsequent post repair evaluation demonstrates an inadequate result.This is likely due to suboptimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the device.In this case, the physician determined that a smaller size annuloplasty ring would be more appropriate for the patient.The device was explanted and replaced with a 26mm annuloplasty ring successfully.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

Manufacturer Narrative

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

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 28MM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5354439
• MDR Text Key: 35456971
• Report Number: 2025587-2016-00025
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101212
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: 690R
• Device Catalogue Number: 690R28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2011
• 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: 00015 YR