MAUDE Adverse Event Report: WL GORE GOR-TEX GRAFT VASC AXILLBFMRL 8X8MMX40; VASCULAR GRAFT

Model Number SAX01D

Device Problem Occlusion Within Device (1423)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Ischemia (1942); Thrombosis (2100); Injury (2348)

Event Date 09/30/2016

Event Type  Injury  

Event Description

On admission was found to have suspected thrombosis/failure of ax-fem graft, given his lle ischemia, underwent ax-fem exploration on (b)(6) which revealed graft disruption requiring ligation of graft 2/2 disruption and bleeding with activation of massive transfusion protocol.The ligation of his graft then by nature led to definitive lle ischemia so he underwent l aka on (b)(6).He recovered well from those operations, however on (b)(6) he began spiking fevers.He had a full sepsis workup including cxr, blood cultures, urine cultures that were negative for any obvious source of infection.He was found to have a deep tissue injury on his sacrum as well as a wound on his scrotum.Wound was consulted and deemed it a necrotic but not superinfected deep tissue injury.His cta was reviewed and he was determined that he likely had no residual pelvic blood flow given his thrombosed and now ligated graft, and that he would likely not survive given his pelvic ischemia, pressure ulcers and fevers.

• Brand Name: GOR-TEX GRAFT VASC AXILLBFMRL 8X8MMX40
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): WL GORE
• MDR Report Key: 6562810
• MDR Text Key: 75153548
• Report Number: MW5069716
• Device Sequence Number: 1
• Product Code: DSY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAX01D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR