MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE GELATIN IMPREGNATED VASCULAR GRAFT

Model Number GELWEAVE

Device Problem Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

Health effect clinical code# 1888, minor blood loss through the graft during the revision surgery to the aortic arch site.Health effect impact code #4613, minor injury, minor blood loss.(b)(4).Type of investigation# 4109, historical data analysis - similar event review relating to the gelweave brand of devices identified an incidence rate of (b)(4).#4111 - communications/interviews - additional discussions with the patients family are expected to gain additional information.(b)(4).Investigation findings code# 3233, results pending completion of investigation - investigation is ongoing.

Event Description

Approximately two years ago, a gelweave graft was implanted within a patient in the usa.The patient now resides in (b)(6).Gelweave type product reported to be leaking by the patient / family.Information provided by the family is as follows: the patient underwent a procedure to treat disease progression within the aortic arch which required open surgery.During this procedure, the original graft (gelweave) situated within the ascending aorta began weeping (not at the anastomosis sites).Blood loss was recorded as 10ml/min.The weeping resolved on its own without intervention.The patient tolerated the blood loss, and was transferred to icu to recover.

Event Description

Approximately two years ago, a gelweave graft was implanted within a patient in the usa.The patient now resides in india.Gelweave type product reported to be leaking by the patient/family.Information provided by the family is as follows: the patient underwent a procedure to treat disease progression within the aortic arch which required open surgery.During this procedure, the original graft (gelweave) situated within the ascending aorta began weeping (not at the anastomosis sites).Blood loss was recorded as 10ml/min.The weeping resolved on its own without intervention.The patient tolerated the blood loss and was transferred to icu to recover.

Manufacturer Narrative

Section h6: health effect clinical code - #1888 - minor blood loss through the graft during the revision surgery to the aortic arch site.Health effect impact code - #4613 - minor injury - minor blood loss.Medical device problem code - #2978 - material integrity issue - the graft is reported to have leaked during a procedure that was not related to this graft.Component code - #4755 - part/component/sub-assembly term not applicable - no known device type.Type of investigation - #4109 - historical data analysis - (b)(4).Type of investigation -#4111 - communications/interviews - additional discussions with the patients family are expected to gain additional information.Type of investigation -#4114 - device not returned - no device is available for evaluation as it remains in situ within the patients anatomy.Investigation findings code - #3221 - no findings available - no additional device or procedural information has been providedby the reporter despite multiple attempts.Investigation conclusion code - #4315 - cause not established.Vascutek considers this event as closed.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE GELATIN IMPREGNATED VASCULAR GRAFT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10565226
• MDR Text Key: 208204058
• Report Number: 9612515-2020-00010
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GELWEAVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other