MAUDE Adverse Event Report: HEART VALVES SANTA ANA RING TRI-AD 900SFC28; RING, ANNULOPLASTY

Model Number 900SFC28

Device Problem Incomplete Coaptation (2507)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 02/04/2016

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 the patient presented with severe tricuspid regurgitation measured on echocardiogram, a dilated tricuspid annulus, extreme shortness of breath, an enlarged heart, and recent onset of rapid atrial fibrillation (afib).The physician noted that the patient had a very thin anterior leaflet, which was shorter than normal and likely contributed to the tricuspid regurgitation.The physician attempted to repair the native tricuspid valve with this annuloplasty ring.The physician placed the device with interrupted sutures and secured these with 2-0 ethibond sutures.The physician stated that this did not look good on a saline test and that there was leakage from redundant tissue on the posterior leaflet.The physician placed a 6-0 prolene suture on a cleft opposite the septal annulus.This improved coaptation, but there was still significant leakage.The physician explanted the device and closed the septal side with two pledgeted 4-0 sutures to create a bicuspid leaflet.Significant tricuspid regurgitation remained, so the physician successfully implanted a medtronic bioprosthetic valve in the tricuspid position.No further adverse patient effects were reported.

Manufacturer Narrative

Added device manufacturing date.

Manufacturer Narrative

Conclusion: investigation results indicated that there are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates an inadequate result.This may likely be due to suboptimal anatomy, surgical technique or inappropriate sizing and not a malfunction of the annuloplasty ring.In this case, this event is attributed to the native valve being unrepairable as the surgical valve replacement was performed.

Manufacturer Narrative

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

• Brand Name: RING TRI-AD 900SFC28
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): HEART VALVES SANTA ANA; 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: 5473834
• MDR Text Key: 39457194
• Report Number: 2025587-2016-00276
• 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,Followup,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 900SFC28
• Device Catalogue Number: 900SFC28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2013
• 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: 00039 YR
• Patient Weight: 122