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 Obstruction/Occlusion (2422)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

This is an event that occurred in (b)(6.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that on (b)(6) 2021 ultrasonography revealed suspended matter in the graft lumen.

Manufacturer Narrative

Manufacturer's investigation conclusion: the ¿suspended matter¿ visible in the submitted images was unable to be identified.The distributor reported that the graft was implanted in the patient¿s forearm on (b)(6) 2019.During a regular follow-up on 24mar2021, an ultrasound reviewed ¿suspended matter¿ in the graft lumen.It was reported that there were no changes in patient condition or anticoagulation that would have contributed to the observation.A still image and video of the ultrasound screen were submitted for review.The cross-sectional view of the vessel appeared to show line-shaped objects overlapping across the center of the lumen.The longitudinal view appeared to show the overlapping objects extending down an unknown length of the graft.The objects were unable to be identified based on review of the imagery.It was reported that there was no issue with patient¿s subsequent medical care following the observation and there are no actions planned to address the issue.No further issues have been reported.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.Occlusion, stenosis, and thrombosis are listed as potential complications with the use of a vascular prosthesis.Intragraft obstruction is listed as a potential complication in table 2 in the summary of vectra vag clinical experience section of the ifu.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information received indicated that what appeared to be a floating substance suspended in the outflow graft was damage to the inner wall of the device.

• 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: 12350409
• MDR Text Key: 267559519
• Report Number: 2916596-2021-04451
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2023
• Device Model Number: 1010880
• Device Lot Number: 53023065-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• 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): Other