MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC CHORD-X 2-0 EPTFE SUTURE 3/8 CIRCLE 16MM; NON-ABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE

Model Number CXL-20-1838-16

Device Problems Failure To Adhere Or Bond (1031); Appropriate Term/Code Not Available (3191)

Patient Problems Regurgitation, Valvular (2335); No Code Available (3191)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, surgeon "implanted a 2-0/ 3/8 needle 16mm chord-x suture system.The papillary stitch pulled out of the papillary muscle so he had to open a second suture 2-0 16mm chord-x kit.[surgeon] then sutured it in to the anterior mitral leaflet (a3 area).He then tested the valve competency and it looked great and held saline.He then implanted a sorin 3d ring around mitral annulus.He then had perfusion fill the heart and had cardiology evaluate the valve with tee.Upon tee evaluation moderate regurgitation was observed and [surgeon] re-opened exposure to evaluate the leak.At that point he discovered the chord-x suture and loops had snapped and was no longer attached to the papillary muscle.It was observed that the suture tore where all three loops come together.He then had to remove the chord-x sutures and sorin ring and abandon the repair and replace the valve with a 32mm medtronic mosaic tissue valve.".

Manufacturer Narrative

According to the initial report, surgeon "implanted a 2-0/ 3/8 needle 16mm chord-x suture system.The papillary stitch pulled out of the papillary muscle so he had to open a second suture 2-0 16mm chord-x kit.[surgeon] then sutured it in to the anterior mitral leaflet (a3 area).He then tested the valve competency and it looked great and held saline.He then implanted a sorin 3d ring around mitral annulus.He then had perfusion fill the heart and had cardiology evaluate the valve with tee.Upon tee evaluation moderate regurgitation was observed and [surgeon] re-opened exposure to evaluate the leak.At that point he discovered the chord-x suture and loops had snapped and was no longer attached to the papillary muscle.It was observed that the suture tore where all three loops come together.He then had to remove the chord-x sutures and sorin ring and abandon the repair and replace the valve with a 32mm medtronic mosaic tissue valve." the following questions were answered by the rep: clarify how 'the papillary stitch pulled out of the papillary muscle'? was a pledget used to anchor the papillary suture prior to tying knots? "yes, both pledgets were used to anchor suture to papillary.We determined that he might not have gotten a good enough bite into good tissue the first time." was the entire initial loops system (including chordal and papillary suture strands) replaced or just the papillary suture strand? "yes, he replace the entire first chord-x suture system and we just opened up a new one." was this an open heart or minimally invasive case? "open heart/ full sternotomy." was the sorin memo 3d rechord or the sorin memo 3d product used in this procedure? "sorin 3d re-chord but he didn't attach the loops to it because he put the ring on after he implanted the chord-x suture system/loops." it looks like there is a step in the implant procedure wherein the chord-x suture is tied to the 3d ring, which could be a reason why both the initial papillary suture 'pulled out' of the papillary muscle, and why the suture assembly broke at the papillary and chordal loop intersection."i get the thought process but he didn't tie chord-x sutures into ring." a sample review was performed on the chord-x 2-0 eptfe suture 3/8 circle 16mm (cxl-20-1838-16, lot z15603000) via visual examination under magnification.Please reference the attached pictures.Image 1 provides a visual representation of all eptfe strands returned.Images 2 - 5 are magnified images of each returned strand.No evidence of natural breakage was found in the returned eptfe strands.Sharp slices nearly entirely through the diameter of the suture were identified in two locations on one of the suture strands near the surgeon tied knot (image 2).Although there was not visual evidence of a natural breaks in the eptfe, evidence of clean cut marks in the returned suture samples was observed.No sharp instruments are used during the assembly or packaging of chord-x.A definitive root cause could not be determined from the examination but it is possible the observed cuts occurred at some point during the surgical procedure.No further action required.The manufacturing records for the chord-x 2-0 eptfe suture 3/8 circle 16mm, cxl-20-1838-16, lot z15603000, were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.

Event Description

According to the initial report, surgeon "implanted a 2-0/ 3/8 needle 16mm chord-x suture system.The papillary stitch pulled out of the papillary muscle so he had to open a second suture 2-0 16mm chord-x kit.[surgeon] then sutured it in to the anterior mitral leaflet (a3 area).He then tested the valve competency and it looked great and held saline.He then implanted a sorin 3d ring around mitral annulus.He then had perfusion fill the heart and had cardiology evaluate the valve with tee.Upon tee evaluation moderate regurgitation was observed and [surgeon] re-opened exposure to evaluate the leak.At that point he discovered the chord-x suture and loops had snapped and was no longer attached to the papillary muscle.It was observed that the suture tore where all three loops come together.He then had to remove the chord-x sutures and sorin ring and abandon the repair and replace the valve with a 32mm medtronic mosaic tissue valve.".

• Brand Name: CHORD-X 2-0 EPTFE SUTURE 3/8 CIRCLE 16MM
• Type of Device: NON-ABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5899792
• MDR Text Key: 52852698
• Report Number: 1649833-2016-00035
• Device Sequence Number: 1
• Product Code: PAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CXL-20-1838-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Other