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 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

The lot number of the product could not be provided.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that an echocardiography revealed an obstruction in the lumen of the artificial vessel.The obstruction was removed with biopsy forceps during a percutaneous transluminal angioplasty (pta) and was revealed to be a reinforcing thread.There were no patient consequences.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of an obstruction could not be confirmed.The graft remains in use and no product or echo images were available for evaluation.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu) (rev u).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 cannulation section of the ifu states that vectra grafts may be punctured for vascular access within 24 hours after implant, provided no contraindications are present.If the blood access needle is inserted such that the angle between the needle axis and the graft is too small, tears in the wall of the graft can occur.This section advises to rotate cannulation sites.Repeated cannulation in the same area may lead to damage of the graft wall and/or formation of hematoma or pseudoaneurysm.Need sites should be equally spaced along the subcutaneous length of the graft.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: 15695566
• MDR Text Key: 306901508
• Report Number: 2916596-2022-14590
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00813024011453
• UDI-Public: 00813024011453
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

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 Catalogue Number: 10002-6050-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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