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

Model Number	690R34
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Right Ventricular Failure (2055); Tricuspid Regurgitation (2112); Heart Failure (2206); No Information (3190); Multiple Organ Dysfunction Syndrome (3261)
Date of Event	08/29/2017
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.
Event or Problem Description
Medtronic received information that 5 years 5 months, post implant of this tricuspid annuloplasty ring, the device was replaced due to unknown reasons.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that 5 years 5 months, post implant of this tricuspid annuloplasty ring, the device was replaced due to severe symptomatic tricuspid regurgitation secondary to worsening liver failure.No additional adverse patient effects were reported as a result of this procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 34MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6908041
• Report Number: 2025587-2017-01745
• Device Sequence Number: 899363
• Product Code: KRH
• UDI-Device Identifier: 00613994845368
• UDI-Public: 00613994845368
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2017

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: 02/23/2017
• Device Model Number: 690R34
• Device Catalogue Number: 690R34
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/29/2017
• 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: 58 YR
• Patient Weight: 119