InjuryMAL
HEMASHIELD MICROVEL DOUBLE VELOUR KNITTED
Received Apr 9, 2018
Report 1640201-2018-00013 · MDR key 7406197
Device
Generic name
Vascular Polyester Graft
Manufacturer
Maquet Cardiovascular LlcProduct problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
NO REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS AND NO DEVICE EVALUATION WERE PERFORMED SINCE THE PRODUCT IDENTIFIER COULD NOT BE OBTAINED AND THE INVOLVED GRAFT WAS NOT AVAILABLE FOR INVESTIGATION. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem
AN 8MM OF HEMASHIELD MICROVEL DOUBLE VELOUR STRAIGHT (UNKNOWN PRODUCT DETAILS) WAS IMPLANTED IN THE PATIENT BY FEMORAL POPLITEAL BYPASS IN 2004. BLOOD LEAKAGE WAS NOTED FROM THE NON-ANASTOMOTIC AREA. THE RE-OP WAS PERFORMED TO REPLACE THE GRAFT. IT WAS UNKNOWN HOW MUCH BLOOD LEAKED. THE SURGERY WAS FINISHED WITH NO ADVERSE EVENT.