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

Model Number 638R

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that during the implant of this 28 mm annuloplasty ring in the mitral position, this ring was implanted, then explanted and replaced during the same procedure by a 29 mm bioprosthetic mitral valve due to moderate regurgitation and anterior and posterior leaflet retraction.No adverse patient effects were reported due to the device's function or due to the replacement procedure.

Manufacturer Narrative

Product analysis: the product specimen was not returned for evaluation.Conclusion: this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.Re-operations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions.Unlike bioprosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.In this case, the ring was explanted due to the patient¿s native valve continued regurgitation.

Manufacturer Narrative

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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5276804
• MDR Text Key: 32996783
• Report Number: 2025587-2015-01293
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2020
• Device Model Number: 638R
• Device Catalogue Number: 638RL28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00074 YR