MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 50CM); PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 10007186

Device Problems Mechanical Problem (1384); Material Split, Cut or Torn (4008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/04/2021

Event Type  Injury  

Event Description

It was reported that during the implant procedure the outer layer was peeled off when the autologous blood vessel and thoratec graft were anastomosed and the needle was passed through.After the procedure, the blood flow was poor, so the technician dissected the autologous blood vessel from the thoratec graft and pulled it to fine-tune the position of the graft resulting in damage.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of damage to the vectra vascular access graft was confirmed during the investigation of the returned section of graft.The customer reported that flow was poor after placing the graft and the technician pulled on the graft to reposition it.Upon pulling the graft, the graft broke.Photographs of the graft were submitted for review, showing the cut ends of the graft and several small splits/tears in the outer layer.The returned section of graft was approximately 16.5cm long.A longitudinal slice extended along approximately 8.5cm of that length.The lumen of the graft was clear contained no depositions or thrombus formations.Visual inspection of the graft under a microscope found multiple small cracks/tears in the outer layer.The observed tears appeared identical to the tears shown in the submitted photographs.No peeling of the outer layer was observed.Review of the manufacturing documentation for the graft lot found no deviations from manufacturing or qa specifications, which includes visual and dimensional inspection of the grafts.Although the specific root cause of the tears in the outer layer could not be conclusively determined, it was reported that the graft was pulled in order to reposition it.The vectra vascular access graft ifu states that the graft should not be pulled (axially elongated) or stretched during handling at implantation.Excessive elongation or stretching of the graft will damage the microporous layers of the graft.Review of the device history records showed no deviations from manufacturing or qa specifications, including visual and dimensional inspection.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu).The ifu states that the graft should not be pulled (axially elongated) or stretched during handling at implantation.The graft should be trimmed long enough to prevent stress on the anastomosis and allow for a full range of body motion when implanted.Excessive elongation or stretching of the graft will damage the microporous layers of the graft.The ifu states that the vectra sheath tunneler should be used to minimize subcutaneous trauma and the force required to position the graft during implant.Tunneling permits graft placement without pulling - which can produce excessive forces that result in damage to the graft microporous layers.When positioning and trimming the graft, avoid those areas of less dense reinforcement, especially near the anastomotic end.The non-reinforced segment must be trimmed to allow for proper sizing of the graft.The tunneling section of the ifu states that the vectra vag tunnelers (except for the full curve tunneler which can only be used the 5mm) can be used with either the 5mm or 6mm vectra vag.Liberally irrigate the inside of the tunneler sheath as well as all surfaces of the graft with a sterile solution of normal physiologic saline to facilitate slipping the graft through the tunneler.Care should be taken to push rather than pull the graft through the tunneler.The vectra vag can be implanted using either a one-sheath or two-sheath technique and instructions for each are provided.These instructions includes steps that ¿insert the vectra vag into the subcutaneously placed sheath and gently push the graft through using a rotating motion if necessary, while irrigating liberally with sterile saline.¿ no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 50CM)
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11497416
• MDR Text Key: 240610325
• Report Number: 2916596-2021-01254
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10007186
• Device Catalogue Number: 10007186
• Device Lot Number: 7297564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1