MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM); PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 1010880

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that before implanting the vectra graft in the patient, it was found that the graft had cracks.The product was replaced with a new one, and there was a comment from the paramedical that the graft may have been pulled to some extent.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of damage to the vectra vascular access graft was confirmed during the investigation of the returned graft.The returned section of graft was approximately 16.125in long.Visual inspection of the graft found multiple splits in the outer layer of the graft.The splits were confined to an area 4.5in to 5.5in from one end of the graft.The remainder of the graft appeared unremarkable.Other areas of the graft were gently twisted, bent, and stretched, which did not generate additional splits in the outer layer.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 splits in the outer layer could not be conclusively determined, it was reported that the graft may have been pulled to some extent before implant.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.Per the drawing for p/n 1010880, the ifu for this product is supplied by goodman, inc., who have taken over this product line.However, graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu) which was still available at the time of manufacture.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 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: 40CM)
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13197402
• MDR Text Key: 287277921
• Report Number: 2916596-2021-07794
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010880
• Device Lot Number: 7196142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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