MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 36MM; RING, ANNULOPLASTY

Model Number	690R
Medical Device Problem Codes	Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/22/2017
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that both a 36 mm tricuspid annuloplasty ring and a 32 mm tricuspid annuloplasty ring were implanted and explanted during the same procedure for unknown reasons.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that the 36 mm tricuspid annuloplasty ring was implanted and explanted as it was leaking post implant prior to the patients chest being closed.As a result the physician placed a smaller 32 mm valve which remains implanted without issue.No additional adverse patient effects were reported.  added weight and updated device code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 36MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7309905
• Report Number: 2025587-2018-00479
• Device Sequence Number: 10982239
• Product Code: KRH
• UDI-Device Identifier: 00643169121720
• UDI-Public: 00643169121720
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 03/02/2018

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: 01/25/2022
• Device Model Number: 690R
• Device Catalogue Number: 690R36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 03/02/2018
• 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: 67 YR
• Patient Weight: 60