MAUDE Adverse Event Report: VASCUTEK LTD GESLOFT; GESLOFT DOUBLE BIFURCATE

Model Number	GESLOFT DOUBLE BIFURCATE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: GESLOFT
• Common Device Name: GESLOFT DOUBLE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 15102475
• Report Number: 9612515-2022-00009
• Device Sequence Number: 14599219
• Product Code: MAL
• UDI-Device Identifier: 05037881110011
• UDI-Public: 05037881110011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P890045/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: GESLOFT DOUBLE BIFURCATE
• Device Catalogue Number: 631809DB
• Device Lot Number: 17299100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown