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

Model Number	900
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Organ Dehiscence (2502); No Information (3190)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Without the receipt of the product, a definitive conclusion cannot 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 one year, four months post implant of this annuloplasty ring in the tricuspid position, this device was explanted and replaced with a bioprosthetic mitral valve.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this ring was replaced due to dehiscence.The physician noted no fault with the ring, but rather poor repair technique.The ring was discarded.No other adverse patient effects were reported.Patient and device codes updated.
Additional Manufacturer Narrative
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.

• 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: 6556283
• Report Number: 2025587-2017-00770
• Device Sequence Number: 802978
• Product Code: KRH
• UDI-Device Identifier: 00643169195370
• UDI-Public: 00643169195370
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K093903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2017

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: 05/31/2020
• Device Model Number: 900
• Device Catalogue Number: 900SFC32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided; 05/03/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/10/2017; 10/03/2017
• 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: 27 YR