MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Mitral Regurgitation (1964); No Information (3190)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Medtronic received information that four years, seven months post implant of this annuloplasty band in the mitral position, this device was explanted and replaced with a bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this device was replaced because the repair was beginning to show signs of regurgitation; moderate regurgitation was observed.Prior to the replacement procedure, the patient presented with fatigue and shortness of breath.The product was discarded and will not be available for analysis.No other adverse patient effects were reported.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.
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: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6544610
• Report Number: 2025587-2017-00741
• Device Sequence Number: 906010
• Product Code: KRH
• UDI-Device Identifier: 00613994758750
• UDI-Public: 00613994758750
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2017

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: 03/14/2017
• Device Model Number: 638B
• Device Catalogue Number: 638BL26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: Not provided; 05/08/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 05/11/2017; 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: 61 YR