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 Problems Rash (2033); Obstruction/Occlusion (2422)

Event Date 09/27/2022

Event Type  Injury  

Event Description

It was reported that after the vectra graft was implanted, the patient developed a systemic rash and redness on (b)(6) 2022.The rash and redness were thought to be caused by a drug-induced allergy.Steroid pulse therapy was performed, but there was no effect.On (b)(6) 2022, the patient was treated for vascular occlusion of the graft.On (b)(6) 2022, the patient was treated again for vascular occlusion.On (b)(6) 2022, there was re-occlusion of the graft.On (b)(6) 2022, the patient had acute occlusion of the graft.The artificial blood vessel patch test was negative.On (b)(6) 2022, the patient had re-occlusion of the graft.On (b)(6) 2022, the vectra graft was removed.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.(b)(4).

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event could not be confirmed.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.Review of the device history records showed no deviations from manufacturing or qa specifications, including visual and dimensional inspection.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: 15709774
• MDR Text Key: 302793494
• Report Number: 2916596-2022-14806
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1010880
• Device Lot Number: 7112708
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer 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
• Patient Outcome(s): Required Intervention