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

Model Number	638BL32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Information (3190)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 6 38bl34, serial/lot #: (b)(4), ubd: 19-oct-2020, udi#: (b)(4).Conclusion: without the return of the products, 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 immediately following the implant of a mitral annuloplasty band, it was explanted and replaced with another band.It is unknown if the 32mm or 34mm band was implanted first.The second mitral band was also explanted immediately after implant and replaced with a non-medtronic product.The reasons for explanting the bands are unknown.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that prior to the procedure, the patient had ruptured mitral valve chordae, resulting in severe prolapse of the posterior leaflet and severe regurgitation.Following resection of posterior leaflet, the 32mm annuloplasty band was lowered into place.There was persistent regurgitation.The surgeon felt this was due to retraction of the "p2" portion of the leaflet.The 32mm band was removed and replaced with a 34mm band of the same model.Residual regurgitation remained, therefore the band was removed and replaced with a 27mm non-medtronic bioprosthetic valve.No additional adverse effects were reported.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: 7993773
• Report Number: 2025587-2018-02807
• Device Sequence Number: 1190091
• Product Code: KRH
• UDI-Device Identifier: 00613994758811
• UDI-Public: 00613994758811
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 11/03/2020
• Device Model Number: 638BL32
• Device Catalogue Number: 638BL32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/19/2018
• 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: 79 YR