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

Model Number 638B

Device Problem Material Deformation (2976)

Patient Problem Regurgitation, Valvular (2335)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned to medtronic.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 Description

Medtronic received information that immediately following implant of this annuloplasty band, it was explanted and replaced due to severe regurgitation, detected by echocardiogram.Preoperative inspection revealed no visual anomalies; however, the physician believes there is a deformity.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received loose, detached from the holder inside the tyvek pouch.The band was discolored showing evidence of blood contact.The holder was received with the band.Tiny cuts and/or tears were observed along the inflow aspect of the band adjacent to both eyelet trigone markers exposing the inner stiffening band.The band appeared intact with no evidence of distortion or fractures.Radiography showed no evidence of distortion and/or fractures along the band.

Manufacturer Narrative

Medtronic received information that immediately following implant of this annuloplasty band, it was explanted and replaced due to severe regurgitation, detected by echocardiogram.As this event was reported to medtronic, the device did not have any visual anomalies prior implant.Device replacement was not reported.There were no anomalies noted on the returned device.The device showed evidence of use.Surgeons often attempt to repair 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 result.This may likely be due to suboptimal anatomy, surgical technique or inappropriate sizing and not a malfunction of the annuloplasty ring.Overall, a true cause cannot be identified.

Manufacturer Narrative

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 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: 5937801
• MDR Text Key: 54262764
• Report Number: 2025587-2016-01432
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2019
• Device Model Number: 638B
• Device Catalogue Number: 638BL26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2014
• 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