MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE COSELLI

Model Number GELWEAVE COSELLI

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605); Insufficient Information (4580)

Event Date 09/23/2023

Event Type  Injury  

Event Description

Graft disruption/ blood leakage/ pseudoaneurysm (suspected): in 2007, a thoracoabdominal aortic replacement was performed using the gelweave coselli thoracoabdominal graft.In (b)(6) 2023, angiographic ct showed what appears to be a pseudoaneurysm near the celiac branch of the graft.On (b)(6) 2024, an attempt was made to locate the pseudoaneurysm during intravascular angiography, which showed leakage from the junction of the main graft body and the celiac branch of the coselli graft.When a catheter was advanced to near the anastomosis of the celiac branch of the graft and the celiac artery, the catheter passed through out of the graft and a disruption was confirmed at the junction of the main graft body and the celiac branch of the coselli graft.The physician initially planned to implant a covered stent additionally and complete the procedure but due to leakage at the junction, he decided that implantation of an additional covered stent would not be effective and determined to treat the patient in a different way later and terminated the procedure.

Manufacturer Narrative

Manufacturer narrative: clinical code: 4580 -insufficient information: leakage reported 16 years post op no device details provided to date , no implant date and no patient outcome.Impact code: 4624 - surgical intervention: the physician initially planned to implant a covered stent additionally and complete the procedure but due to leakage at the junction, he decided that implantation of an additional covered stent would not be effective and determined to treat the patient in a different way later and terminated the procedure.Medical device problem: 2993 -adverse event without identified device or use problem: leakage reported however cause cannot be confirmed and will be investigated once more information is received.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4111 - communication interview: additional information has been requested from the site 4114 - device not returned: device remains implanted implant date in section d6a has been added as on (b)(6) 2007 as the site have only reported 2007 for implant , when this is updated it will be communicated in the next available report.

Event Description

This report is being submitted as follow up #1 for mfg.Report to provide event closure information for comp no (b)(4).

Manufacturer Narrative

Manufacturer narrative: clinical code: 4580 -insufficient information: leakage reported 16 years post op no device details provided to date , no implant date and no patient outcome.No device identification provided 2605 - pseudoaneurysm near the celiac branch of the graft.Additional information was received to say there was another aneurysm in the internal iliac artery.Impact code: 4624 - surgical intervention: the physician initially planned to implant a covered stent additionally and complete the procedure but due to leakage at the junction, he decided that implantation of an additional covered stent would not be effective and determined to treat the patient in a different way later and terminated the procedure.Further information received on 28 apr 24 confirmed on 26 march 2024, an additional treatment was performed.The details are as follows.Intergard quadrifurcated (getinge) was used to replace the y graft including reconstruction of the internal iliac artery.The great saphenous vein was used for bypass from the common iliac artery to the common hepatic artery.After implantation of an endurant cuff (3232-70, medtronic) just above the sma, an excluder cuff (3204, gore) was implanted inside the y-graft.Medical device problem: 3190 - an adverse event appears to have occurred but there is not yet enough information available to classify the device problem.).: leakage reported however cause cannot be confirmed no investigation in to this event was possible as no device details were provided and no graft was returned.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4111 - communication interview: additional information was requested from the site.4114 - device not returned: device remains implanted investigation findings: 3221 - no findings available, 3 attempts were made for further information on this event, no device details were communicated therefore no review of batch records could be performed and as the device remained implanted no further investigation could be carried out.Investigation conclusion: 67 - cause not established, the device complaint or problem cannot be confirmed.) no causal link could be determined between the event and the device.Implant date in section d6a has been added as 01/01/2007 as the site have only reported 2007 for implant , no confirmation of implant date was communicated.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE COSELLI
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 18904541
• MDR Text Key: 337765407
• Report Number: 9612515-2024-00015
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GELWEAVE COSELLI
• Device Catalogue Number: 732410108/8S4-J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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