MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 50CM); PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 10007186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 01/27/2022

Event Type  Injury  

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 the patient was injured by access failure during dialysis puncture on (b)(6) 2022.On (b)(6) 2022 the area developed tenderness and a subcutaneous hematoma was noted.The patient underwent thrombus aspiration due to reocclusion of the arteriovenous graft (avg), and, after a scan with contrast, a highly stenotic lesion localized to the ulnar end of the loop where it was punctured by dialysis was found.This was thought to be the starting point of the occlusion, and vascular access intervention therapy (vaivt) was performed.On (b)(6) 2022 the lesion could not be removed and was partially replaced with thoratec 5-20.The patient's symptoms improved thereafter.When the specimen was removed, reinforcing thread was found protruding in the inner layer of the graft, at the puncture site.It was expected that a part of the cut reinforcement was pushed out to the lumen by the puncture operation.

Manufacturer Narrative

This event took place on (b)(6) surgery in tokyo, japan.Manufacturer's investigation conclusion: the cause of the reported hematoma and graft obstruction could not be conclusively determined based on the evaluation of the returned graft segment.The graft segment measured approximately 1in long and had been cut open longitudinally.The graft was very stiff due to graft, tissue, and blood being dried out.Visual inspection noted a circumferential fold in the inner graft layer.The graft was placed in a cleaning solution to remove the ingrown tissue.Upon removal, the graft was noted to be very pliable and the previously observed fold was no longer present.Visual inspection of the graft under a microscope was unable to locate the reported needle puncture hole.The report of the graft reinforcement protruding into the graft lumen was not confirmed as no portion of the monofilament was observed during inspection.The evaluation was unable to conclusively determine if the circumferential fold was the cause of the reported stenosis or if it was an artifact of the graft drying out.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 formation of hematomas or pseudoaneurysms 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 provides information regarding dialysis and insertion of a needle.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 provided.The manufacturer is closing the file on this event.

• Brand Name: VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 50CM)
• 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: 13662060
• MDR Text Key: 287202065
• Report Number: 2916596-2022-00929
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00813024013525
• UDI-Public: 813024013525
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: 10007186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2018
• 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): Required Intervention; Hospitalization