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

Model Number	900SFC32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tricuspid Regurgitation (2112); No Information (3190)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Medtronic received information that during the implant of this 32mm annuloplasty ring in the tricuspid position, the ring was explanted and replaced for unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Added device manufacture date.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received additional information that post implant of this annuloplasty ring, transesophageal echocardiogram (tee) revealed tricuspid regurgitation due to right ventricular dilation and leaflet tethering.The physician elected to replace the valve.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: RING TRI-AD 900SFC32
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7635016
• Report Number: 2025587-2018-01568
• Device Sequence Number: 16526261
• Product Code: KRH
• UDI-Device Identifier: 00643169195370
• UDI-Public: 00643169195370
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 900SFC32
• Device Catalogue Number: 900SFC32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 06/28/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 06/26/2018; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80