MAUDE Adverse Event Report: THORATEC CORPORATION GRAFT, 5MM 24-32 WP REINFORCE

Model Number 1010880

Device Problem Infusion or Flow Problem (2964)

Patient Problems Inflammation (1932); Thrombus (2101)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the graft was implanted in the patient on (b)(6) 2018.It was reported that the patient had an inflammatory reaction which first started at the site of implantation, but later spread to the whole body.An occlusion in the graft was also reported on (b)(6) 2018.It was reported that due to the thrombotic occlusion, the inflammatory reaction spread to the whole body.There was no occurrence of fever, and blood tests showed eosinophils and neutrophils values stayed within normal range.The patient was prescribed antihistamine and antibiotic medication.The inflammatory reaction subsided and the graft was explanted on (b)(6) 2018.The inflammatory reaction resolved completely after removal.No further information was provided.

Manufacturer Narrative

Manufactures investigation conclusion: the reported event, of a graft infection due to the vectra revision graft implant in the forearm, was inconclusive.No product or product sample was returned for evaluation.The explanted graft was discarded by the surgeon.The patient was reported to have a localized infection in the graft area ¿ one-day post-implant.The reaction was reported to have that spread systemically.An occlusion in the graft was also noted to have occurred approximately two days post-implant.The patient was treated with antibiotics over two-week period.This resolved the reactions.However, the graft was eventually explanted ¿ approximately 44 days post-implant.The reported reactions resolved after the graft was explanted.A specific cause for the reported infection could not conclusively be determined through this evaluation.Possible complications associated with vectra graft implants are addressed in the vectra vag instructions for user and associated risk assessment documents.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: GRAFT, 5MM 24-32 WP REINFORCE
• Type of Device: GRAFT, 5MM 24-32 WP REINFORCE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7561488
• MDR Text Key: 109831384
• Report Number: 2916596-2018-02105
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1010880
• Device Catalogue Number: 1010880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR