MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT WITH GRADUATED REINFORCEMENT; PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Model Number	10007186
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .
Event or Problem Description
When the vectra graft was implanted under the skin and pulled near the top of the loop, a crack appeared in the outer layer, so it was discontinued and removed.
Additional Manufacturer Narrative
This event occurred at (b)(6) hospital in (b)(6) japan manufacturer's investigation conclusion: the report of damage to the vectra vascular access graft was confirmed during the investigation of the returned graft.The graft measured approximately 16 1/8 inches long and showed tearing in the outer layer near the midpoint.Visual inspection also found tool-mark shaped tears on one end of the graft.The marks were positioned 180-degrees apart and the adjacent area showed additional tearing.The monofilament reinforcement was protruding from several of the graft tears.Review of the manufacturing documentation for the graft lot found no deviations from manufacturing or quality assurance specifications, which includes visual and dimensional inspection of the grafts.Review of the device history records showed no deviations from manufacturing or quality assurance 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.
Event or Problem Description
It was reported that the patient was stable.

• Brand Name: VECTRA VASCULAR ACCESS GRAFT WITH GRADUATED REINFORCEMENT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM 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: 13652392
• Report Number: 2916596-2022-00943
• Device Sequence Number: 2369954
• Product Code: DYF
• UDI-Device Identifier: 00813024011323
• UDI-Public: 00813024011323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 10007186
• Device Catalogue Number: 10002-5040-001
• Device Lot Number: 6921906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown