MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE VALSAVLVA; GELWEAVE VALSALVA

Catalog Number 734024/10ADP-J

Device Problem Material Integrity Problem (2978)

Patient Problem Perforation of Vessels (2135)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

No graft details have been provided to date.Implant date given as 2016 , no specific date was noted.(b)(4).Medical device problem code: (b)(4).Component code: (b)(4).Type of investigation: (b)(4).

Event Description

Event reported as leakage.First surgery in 2016 the patient underwent aortic root replacement using a magna bioprosthetic valve (edwards lifesciences) and the gelweave valsalva graft (composite) and aortic arch replacement using a 4-branch hemashield graft (cosmotec) at a hospital in hiroshima, not at the sakakibara memorial hospital.A 3.0 braided suture was used for the graft anastomosis site.Second surgery in 2018 there was bleeding from the anastomosis site between the valsalva graft and the 4-branch hemashield graft, and bleeding was noted on the valsalva graft side.The bleeding site was reinforced with a suture with pledget.Surgery on (b)(6) 2022.There is a continuous bleeding tendency.Only the bleeding portion of the valsalva graft was excised and was replaced with triplex.A 5.0 monofilament suture was used for graft anastomosis.A short triplex was wrapped around the replaced area from outside and reinforced to prevent bleeding.The patient's condition is stable after the surgery.The excised graft that appeared to be bleeding was collected.The exact size and the lot number of the valsalva graft are unknown.Operation type: aortic root replacement and aortic arch replacement blood loss: unknown ancillary device used: 4-branch hemashield graft (cosmotec).

Manufacturer Narrative

Manufacturer narrative : investigation findings : no device details were provided , however a section of the graft was returned for analysis and holes were found where the sutured pledget was placed.Investigation conclusion: (b)(4)- cause not established.Analysis has found a hole in the graft that has been repaired using a sutured pledget.The testing suggests that the hole has been caused by a sharp implement, although it could not determine how or when the hole was created the cause of the original damage to the device is unknown, however, it is unlikely to have been caused during manufacture as a hole this size would have been found during visual inspection and porosity testing at terumo aortic.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 Description

This report is being submitted as follow up #1 for mfg.Report #9612515-2023-00001 to provide event closure information for comp no.(b)(4).

• Brand Name: GELWEAVE VALSAVLVA
• Type of Device: GELWEAVE VALSALVA
• 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: 16102550
• MDR Text Key: 306712691
• Report Number: 9612515-2023-00001
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013022
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 734024/10ADP-J
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• 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