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 Thrombosis/Thrombus (4440)

Event Date 12/28/2022

Event Type  Injury  

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.Reporter phone number line 1: (b)(6).Reporter postal office or zip code: (b)(6).

Event Description

It was reported that an echocardiogram (echo) revealed a reinforcement thread had popped out of the vectra graft.Biopsy forceps were used to remove the thread, as shunt blood flow was low and a thrombus had adhered to the thread.This event was likely due to frequent punctures to the same point on the side of the artery near the first and second points.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a reinforcing thread in the lumen of the graft could not be confirmed.The customer reported that a linear material was observed in the lumen of the graft via echocardiography.It was indicated that this was the fourth occurrence of this observation with the patient and was believed to be caused by the graft being punctured during dialysis.It was also noted that blood flow was low and thrombus tended to adhere in the area.The material was removed using biopsy forceps.A photograph and infrared spectrum were provided for review.The photo appeared to show a strand of material consistent with the reinforcing monofilament.The provided spectrum was dated 12oct2022 and was reportedly comparing the material removed from the patient¿s graft to a sample of the monofilament, which appeared to be a match.However, the files provided for review appeared to be from one of the patient¿s prior incidents and not the event on 28dec2022.The device history records could not be reviewed because the lot number of the graft was reported to be unknown.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.Needle 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: 16268103
• MDR Text Key: 308422939
• Report Number: 2916596-2023-00392
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention