GESLOFT
Received Jul 26, 2022 · Event occurred May 1, 2022
Report 9612515-2022-00009 · MDR key 15102475
Device
Generic name
Gesloft Double Bifurcate
Manufacturer
Vascutek LtdModel number
GESLOFT DOUBLE BIFURCATECatalog number
631809DB
Lot number
17299100
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FURTHER ACTION IS NOT PLANNED, HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.
Description of Event or Problem
ON (B)(6) A PATIENT HAD A GELSOFT DOUBLE BIFURCATE DEVICE IMPLANTED. IN AN UNCONFIRMED DAY IN MAY 22 THE PATIENT ATTENDED A FOLLOW UP EXAMINATION WHERE IT WAS DETECTED THAT THE GELSOFT DEVICE WAS LEAKING WITHIN THE RIGHT EXTERNAL ILIAC. ON (B)(6) AN INTERVENTION WAS PERFORMED WHEREBY A GORE MANUFACTURED EXCLUDER DEVICE WAS IMPLANTED TO ARREST THE BLEEDING. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT SUFFERED NO REPORTED DAMAGE.