MAUDE Adverse Event Report: HEART VALVES SANTA ANA CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/26/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.Additional information has been requested, but no new information has been received to date.
Event or Problem Description
Medtronic received information that immediately post implant of this annuloplasty band in the mitral position, this device was explanted.No failure mechanism and no adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this 30mm annuloplasty band was explanted and replaced due to severe systolic anterior motion (sam) with severe regurgitation.The physician thought this band was too small, so it was replaced with a 34mm annuloplasty band.After replacement with a 34mm band, no sam and no regurgitation was present.Patient's relevant medical history updated.Patient and device codes updated.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
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6188122
• Report Number: 2025587-2016-02046
• Device Sequence Number: 16359303
• Product Code: KRH
• UDI-Device Identifier: 00613994758798
• UDI-Public: 00613994758798
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/11/2017

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: 06/07/2021
• Device Model Number: 638B
• Device Catalogue Number: 638BL30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided; 01/11/2017; 01/11/2017
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/11/2017; 09/27/2017; 09/28/2017
• 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: 51 YR
• Patient Weight: 71