MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Model Number GELSOFT PLUS BIFURCATE

Device Problem Material Integrity Problem (2978)

Patient Problem Aneurysm (1708)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative: health effect: 1708 - aneurysm: on (b)(6) 2023, blood leakage was observed from the bifurcation of the graft, causing the aneurysm to enlarge.Impact code: 4625 - additional surgery was performed.4624 - surgical intervention - further surgery was needed to remove device.4627 - device explanation - device was implanted on (b)(6) 2011, device was explanted on (b)(6) 2024 and is being returned for investigation.4642 - additional device was required - a vascular graft was implanted on (b)(6) 2024.Medical device problem code: 2978 - material integrity problem - bifurcate was explanted and a hole was found at the bifurcation of the graft.Component code: 4755 - part / component/ sub-assembly code not applicable - this device has no component parts.

Event Description

The patient underwent the procedure with the gelsoft plus (so-631206p, 12mm x 6mm) for aaa on (b)(6) 2011 and there were no problems after the procedure.On (b)(6) 2023, blood leakage was observed from the bifurcation of the graft, causing the aneurysm to enlarge.Ivr treatment was considered, but the left branch of the graft was stenosed, and the patient underwent open surgery on (b)(6) 2024.The implanted graft was removed, and a hole was found at the bifurcation of the graft.Surgery was performed with a vascular graft (manufacturer and specifications unknown) and was successfully completed.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18657164
• MDR Text Key: 334724486
• Report Number: 9612515-2024-00006
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631206P
• Device Lot Number: 93461/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other