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

Model Number 638B

Device Problem Fracture (1260)

Patient Problem Mitral Regurgitation (1964)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, however, the return is anticipated.Conclusion: multiple attempts to gather additional information 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.(b)(4).

Event Description

Medtronic received information that 10 months post implant of this mitral annuloplasty band, the patient presented with severe paravalvular leak and severe central regurgitation caused by a type 1 fracture in the middle of the device.The device was explanted and replaced with a non-medtronic valve.No further adverse patient effects were reported.

Manufacturer Narrative

Analysis: the device was received in a cloudy solution in a plastic specimen cup.The band appeared slightly distorted.Green and white multifilament sutures remained attached to the cloth covering the band, and six loose metal clips, from an unknown manufacturer, were returned along with the band.Off-white pannus was attached to the body of the band.Radiography showed a fracture of the stiffener.The fractured piece with the eyelet appeared to have moved or dislocated outwards.Five metal clips were visibly attached to the band in the x-ray image.No calcification was noted.Conclusion: the investigation is ongoing.Additional information will be submitted in a supplemental report if, and when, it becomes available.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Initial analysis of the returned device confirmed the reported fracture.A break in the band and a twisted band segment were identified via x-ray imaging.The device was sent for optical inspection and fractographic analysis completed using digital optical microscopy and scanning electron microscopy (sem).The analysis concluded that: the wire stiffener component of the device fractured during in vivo operation.The device fractured away from the mid-span of the wire as a result of cyclic (i.E.Fatigue) bending loads.The initiation sites of fracture were closely examined.Some surface anomalies were observed.It was possible that such anomalies were implicated in the development of the fracture.The origin of the surface anomalies were unknown, but were not likely caused by a scalpel or needle.The fracture surface of the device matched with reverse bending under nominal stresses loading conditions.Based on the analysis, a conclusive cause of the fracture could not be determined.The reported severe paravalvular leak and severe central regurgitation were likely due to the fracture.The instructions for use of the device includes ring/band fracture in the potential adverse events section.Medtronic adjusted the specification for the titanium stiffening wire under (b)(4).This material change was implemented september 2004.The device reported in this event was manufactured after the material change.The current rate of occurrence for this event type (i.E.The occurrence of a fracture of the stiffener leading to reoperation) has not exceeded the predicted rate of occurrence.

• 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: 5442403
• MDR Text Key: 38410304
• Report Number: 2025587-2016-00197
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2015
• Device Model Number: 638B
• Device Catalogue Number: 638BL38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• 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: 00068 YR
• Patient Weight: 80