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 Infusion or Flow Problem (2964)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that foreign matter near the anastomotic site on the venous side of the vectra graft was confirmed via echocardiogram (echo).The physician covered the foreign matter with a graft.

Manufacturer Narrative

The event date was estimated as the exact date of the event was unknown.The reported event occurred at (b)(6) university school of medicine in kawasaki, japan.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of foreign matter near the anastomotic site of the graft could not be confirmed.The material was reportedly observed via echo on the venous side of the artificial blood vessel.There was no trace of puncture near the site.Removal of the material was considered before it was decided to cover the material with a stent.It was indicated that there was no thrombus and no adverse impact to the patient as a result of the issue.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).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.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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was unclear if it was a delamination or a reinforcing thread.There was no impact on the patient.

• 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: 15117064
• MDR Text Key: 304550320
• Report Number: 2916596-2022-12466
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 1010880
• Device Lot Number: 185133-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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