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

Model Number 638RL

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); No Information (3190)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that immediately post implant of this annuloplasty ring in the mitral position, this ring was explanted and replaced because the physician "was not happy with the ring." no particular failure mode and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this product was replaced because the attempted repair with this annuloplasty ring failed due to severe regurgitation.The patient¿s native valve was subsequently replaced with a bioprosthetic valve.The patient had a post-operative course lasting 34 days, with multi organ failure, acute renal failure, liver dysfunction, multiple strokes, arrhythmias, dysplasia.These effects were not directly attributed to the annuloplasty ring.The patient did recover, and was discharged to rehabilitation.The patient was very deconditioned, requiring mechanical breathing and the patient had severe neurological deficits.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

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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6124341
• MDR Text Key: 60787831
• Report Number: 2025587-2016-01847
• 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: 01/05/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2020
• Device Model Number: 638RL
• Device Catalogue Number: 638RL30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided; 01/05/2017
• Supplement Dates FDA Received: 01/05/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2015
• 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: 74 YR
• Patient Weight: 107