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	Death (1802); No Information (3190)
Date of Event	01/23/2017
Type of Reportable Event	Death
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 the device be returned or additional information become available, a supplemental report will be submitted.
Event or Problem Description
Medtronic received information that immediately post implant of this annuloplasty band, this device was explanted.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Multiple requests for additional information have been made to the physician's practice regarding this patient, but the physician's practice has declined to provide additional information citing patient confidentiality.Additional information has also been requested from the hospital system, but no information has been received.
Event or Problem Description
Medtronic received additional information that the patient expired.The date of death was not provided.No cause of death and no device involvement was reported, nor was any allegation received that the product contributed to the patient¿s death.
Additional Manufacturer Narrative
Analysis: the device was not returned for investigation.Multiple attempts to obtain additional information were made, but no new information was received.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Surgeons often attempt to repair mitral valves in lieu of replacing them due to improved long term clinical outcomes.There are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates an inadequate results.This is often due to suboptimal anatomy, surgical technique, or inappropriate sizing, and not a malfunction of the device.In this case, medtronic received information that immediately post implant of this annuloplasty band in the mitral position, this device was explanted.No failure mechanism and no other adverse patient effects were reported.Medtronic received additional information that the patient expired.The date of death was not provided.No cause of death and no device involvement was reported, nor was any allegation received that the product contributed to the patient¿s death.Conclusion: based on the limited received information, the failure mode cannot be determined, no risk analysis review is required and no formal investigation is recommended.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.

• 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: 6344095
• Report Number: 2025587-2017-00269
• Device Sequence Number: 19063773
• Product Code: KRH
• UDI-Device Identifier: 00613994758750
• UDI-Public: 00613994758750
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• 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,Followup,Followup
• Report Date (Section B): 04/25/2017

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: 01/03/2021
• Device Model Number: 638B
• Device Catalogue Number: 638BL26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/25/2017
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 04/03/2017; 04/26/2017; 09/29/2017
• 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: Death; Required Intervention
• Patient Age: 78 YR