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

Model Number 638BL30

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Mitral Regurgitation (1964)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that immediately post implant of this 30mm mitral annuloplasty band, it was explanted and replaced with an unknown device.The reason for replacement was reported as residual mitral regurgitation.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this 30mm mitral annuloplasty band was replaced with an annuloplasty band of the same model.It was reported there was no malfunction of the 30mm band.No additional adverse patient effects were reported.A4: patient weight added d10: device available for evaluation? updated h3: device evaluated? updated h6: coding updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination showed the band was discolored and stained, showing evidence of blood contact.Minor cloth damages were noted along the band, which was likely due to the implantation process.Conclusions: surgeons often attempt to repair valves in lieu of replacing them in an effort to preserve the native anatomy.There are times when valve repair is attempted using a repair device and subsequent post-repair evaluation demonstrates an inadequate result.This is potentially due to, but not limited to, suboptimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the device.H3: device evaluated? updated h6: coding updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10154121
• MDR Text Key: 195132608
• Report Number: 2025587-2020-01914
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169793606
• UDI-Public: 00643169793606
• Combination Product (y/n): N
• PMA/PMN Number: K052860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 638BL30
• Device Catalogue Number: 638BL30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 78