MAUDE Adverse Event Report: HEART VALVES SANTA ANA CG FUTURE BAND; RING, ANNULOPLASTY

Model Number 638BL30

Device Problem Incomplete Coaptation (2507)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned for device evaluation.Conclusion: multiple attempts to request additional information and 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 Description

Medtronic received information that 1 years 6 months post implant of this mitral annuloplasty ring, the patient's native valve tissue had a prolapse.The physician explanted the device and implanted a bioprosthetic valve.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information received indicates that the patient's device did not cause or contribute to the valve prolapse.The patient experienced cardiogenic shock, extracorporeal membrane oxygenation (ecmo), renal insufficiency, and post operative bell's palsy.

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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 5709543
• MDR Text Key: 46909673
• Report Number: 2025587-2016-00851
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052860
• 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: 06/13/2016

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: 10/26/2016
• Device Model Number: 638BL30
• Device Catalogue Number: 638BL30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided; 06/13/2016
• Supplement Dates FDA Received: 06/14/2016; 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2011
• 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: 76 YR
• Patient Weight: 101