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

Model Number GELWEAVE

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem Aneurysm (1708)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer stated that anastomosis on the heel part of the branch body where the lower side branch was anastomosed with the side of the sma was insufficient, resulting in blood leakage.Testing of explanted section of graft will be carried out.Historical data analysis: a 5-year similar event review for leakage of gelweave devices was carried out giving an occurrence rate of 0.012% analysis of production records: review of qc and manufacturing records show that the batch was manufactured to specification: no issues were found with base material of in-process leakage testing.No device problem found: review of device qc and manufacturing records showed device was manufactured to design specification conclusion not yet available: vascutek has requested further information from site to clarify event and will report findings in next follow up / final report.

Event Description

Blood leakage (branch): the patient had aaa.After aaa was treated, the gelweave trifurcate was used for thoracoabdominal aorta debranching.A guide sheath for a stent graft (24 fr dryseal sheath) was inserted into the 12-mm graft body of the gelweave trifurcate and the other end was anastomosed with the celiac artery.The upper 8-mm side branch was anastomosed with the right renal artery, and the lower side branch was anastomosed with the side of the sma.The anastomosis on the heel part of the branch body where the lower side branch was anastomosed with the side of the sma was insufficient, resulting in blood leakage.The heel part was sutured with a few stitches to achieve hemostasis.Since hemostasis was successfully achieved, the gelweave trifurcate was implanted without replacement.Subsequently, the procedure was successfully completed without any health damage.Operation type: thoracoabdominal aorta debranching associated with endovascular aortic repair.

Manufacturer Narrative

Corrected data: section h6: previous initial report indicated that investigation of explanted device would be performed - this was incorrect as device remains implanted and was not returned for investigation.Manufacturer narrative.Section h6.Patient code - 1708 - aneurysm - patient was being treated for aaa.Device code - 2978 - material integrity problem.Device code - 2205 - material perforation.Device code - 1504 - material puncture/hole - the customer stated that anastomosis on the heel part of the branch body where the lower side branch was anastomosed with the side of the sma was insufficient, resulting in blood leakage.Method code - 4109 - historical data analysis - a 5-year similar event review for leakage of gelweave devices was carried out giving an occurrence rate of 0.012% method code - 3331 - analysis of production records - review of qc and manufacturing records show that the batch was manufactured to specification - no issues were found with base material of in-process leakage testing.Method code - 4111 - communication/interviews - additional information was requested and received from site however no new information received gave any indication of what led to leakage event.Result code - 213 - no device problem found - review of device qc and manufacturing records showed device was manufactured to design specification.Conclusion code - 4315 - cause not established - review of device qc and manufacturing records or information received from site did not indicate a root cause of the leakage observed.As no further information will be received and device was not returned for investigation vascutek ltd.Now considers this complaint closed.

Event Description

Blood leakage (branch): the patient had aaa.After aaa was treated, the gelweave trifurcate was used for thoracoabdominal aorta debranching.A guide sheath for a stent graft (24 fr dryseal sheath) was inserted into the 12-mm graft body of the gelweave trifurcate and the other end was anastomosed with the celiac artery.The upper 8-mm side branch was anastomosed with the right renal artery, and the lower side branch was anastomosed with the side of the sma.The anastomosis on the heel part of the branch body where the lower side branch was anastomosed with the side of the sma was insufficient, resulting in blood leakage.The heel part was sutured with a few stitches to achieve hemostasis.Since hemostasis was successfully achieved, the gelweave trifurcate was implanted without replacement.Subsequently, the procedure was successfully completed without any health damage.Operation type: thoracoabdominal aorta debranching associated with endovascular aortic repair.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE TRIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10372345
• MDR Text Key: 231723180
• Report Number: 9612515-2020-00007
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881998077
• UDI-Public: 05037881998077
• Combination Product (y/n): N
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/09/2020,09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: GELWEAVE
• Device Catalogue Number: 732012/8X2
• Device Lot Number: 17700610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2020
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention