MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM; RING, ANNULOPLASTY

Model Number	690R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tricuspid Regurgitation (2112)
Date of Event	10/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 2.3 months post implant of this annuloplasty ring in the tricuspid position, the ring was explanted and replaced with a bioprosthetic valve.An echocardiogram showed no regurgitation after implant, however, over the weeks, the patient showed more signs of right heart problems and severe tricuspid regurgitation.The surgeon reported there was no failure of the ring, but that the patient's condition changed.No adverse patient effects were reported.

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7001193
• Report Number: 2025587-2017-02024
• Device Sequence Number: 13827029
• Product Code: KRH
• UDI-Device Identifier: 00643169121676
• UDI-Public: 00643169121676
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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: 11/13/2021
• Device Model Number: 690R
• Device Catalogue Number: 690R26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/03/2017
• 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: 68 YR