MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD; PROSTHESIS, VASCULAR GRAFT

Device Problem Leak/Splash (1354)

Patient Problem Death (1802)

Event Date 11/24/2015

Event Type  Death  

Event Description

The hosp reported that during an aortic dissection vascular replacement surgery, the pt experienced intraoperative bleeding especially the exhaust hole hemorrhaging.Errhysis more after suture bleeding hole, 500-600ml/h.The hemostatic effect was not good, the pt eventually died of hemorrhagic shock.Internal complaint (b)(4).

• Brand Name: INTERGARD
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; la ciotat ; FR
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 0000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 5326496
• MDR Text Key: 34331537
• Report Number: 3008355164-2015-00166
• Device Sequence Number: 1
• Product Code: DSY
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2015
• 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): Death