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

Catalog Number	733028
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 1690 -abscess identified during planned re-do procedure.Impact code: 4630 - modified surgical procedure, planned re do was for suspected prosthetic valve endocarditis while replacing the prosthetic valve, they also removed and replaced the infected gelweave graft.Device problem code: 3190 - insufficient information - no device failure /deficiency has been reported.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 4-year review of similar complaints (gelweave sales jan 21 - dec 24 vs gelweave infection events jan 21 - aug 24) gave an occurrence rate of(b)(4) no trend requiring action has been identified.4111 - communication interview: additional information 3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture 4114 - device was explanted during the re-do procedure on (b)(6) 2024.It is indicated it is not available for return, we have requested the disposition of the explanted graft.Investigation findings: 3233 - results pending completion of investigation conclusion: 11 - conclusion not yet available as investigation is ongoing.
Event or Problem Description
Event date: 15 oct 24 implant date: on (b)(6) 2021.Event reported form panther study) (6) subject (b)(6), a 43-year-old, white, male with an ascending aorta aneurysm, experienced a serious adverse event of abscess.The subject underwent an open surgical repair with a gelweave straight device on (b)(6) 2021.On post operative day 1072 (b)(6)2024), the subject experienced the serious adverse event of abscess.The patient presented to the emergency department with a fever of 103.1f.Patient stated this is the same way he felt the last time he had endocarditis that led to initial gelweave procedure.Patient was discharged but later brought back to the emergency department after he continued to have fevers that worsened with other symptoms.Imaging on (b)(6) 2024, revealed a paravalvular leak and started on antibiotics for suspected endocarditis.Planned re-do procedure on (b)(6) 2024 where an abscess was found and cultures taken that came back positive.Gelweave device was explanted during re-do procedure on (b)(6) 2024.The subject was discharged on (b)(6) 2024.As the device was explanted, the subject will no longer be followed up in the study.The investigator considered the event of abscess to be possibly related to the device.Event was reported as possibly related to the device, procedure and not related to a pre-existing condition.The event was considered resolved without sequelae.
Event or Problem Description
Event date: 15 oct 2024.Implant date: (b)(6) 2021.Event reported form panther study ((b)(6)) subject (b)(6), a 43-year-old, white, male with an ascending aorta aneurysm, experienced a serious adverse event of abscess.The subject underwent an open surgical repair with a gelweave straight device on (b)(6) 2021.On post operative day 1072 ((b)(6) 2024), the subject experienced the serious adverse event of abscess.The patient presented to the emergency department with a fever of 103.1f.Patient stated this is the same way he felt the last time he had endocarditis that led to initial gelweave procedure.Patient was discharged but later brought back to the emergency department after he continued to have fevers that worsened with other symptoms.Imaging on (b)(6) 2024, revealed a paravalvular leak and started on antibiotics for suspected endocarditis.Planned re-do procedure on (b)(6) 2024 where an abscess was found and cultures taken that came back positive.Gelweave device was explanted during re-do procedure on (b)(6) 2024.The subject was discharged on (b)(6) 2024.As the device was explanted, the subject will no longer be followed up in the study.The investigator considered the event of abscess to be possibly related to the device.Event was reported as possibly related to the device, procedure and not related to a pre-existing condition.The event was considered resolved without sequelae.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00004 to provide event closure information for tag0127.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 1690 -abscess identified during planned re-do procedure.Impact code: 4630 - modified surgical procedure , planned re do was for suspected prosthetic valve endocarditis while replacing the prosthetic valve, they also removed and replaced the infected gelweave graft.The event was considered resolved without sequelae.Device problem code : 2993 - - adverse event without identified device or use problem - full batch review was performed for gelweave batch i.D 21726238 form base fabric to finished product which confirmed the batch was manufactured to specification.Temperature and humidity for the period of manufacture was also within specification.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 4-year review of similar complaints (gelweave sales jan 21 - dec 24 vs gelweave infection events jan 21 - aug 24 )gave an occurrence rate of 0.001% no trend requiring action has been identified.4111 - communication interview: additional information - patient was given vancomycin pre-operatively once, at 333.3 millilitres / hour administered over 1.5 hours starting 11/08/2021 at 0723 and ending at 1334.Cefuroxime was then given, at 200 millilitres / hour administered over 30 minutes starting (b)(6)2021 at 1426 and ending (b)(6)2021 at 1250, operating room cultures returned with gram positive culture with suspicion for streptococcus species.The graft is not available for return as it has been disposed of.3331 - analysis of production records : full batch review was performed for gelweave batch i.D 21726238 form base fabric to finished product which confirmed the batch was manufactured to specification.Temperature and humidity for the period of manufacture was also within specification.Biological indicators passed as per mcp002 - sterilisation control procedure , endotoxin results passed as per mcp005 endotoxin testing of product and water procedure , sterilisation control sheets were verified and passed to sps001 steriliser acceptance criteria specification.Results withing specification.4114 -device not returned - device was explanted during the re-do procedure in 31 oct 2024 and disposed of.Investigation findings: 213 - no device problem found - device was manufactured/ and sterilised to specification.Investigation conclusion: 4315 - cause not established.- as device was manufactured to specification and streptococcus spp.Has not been detected in any microbial testing of terumo aortic glasgow products, nor in any environmental monitoring or cleanroom areas.The sterilisation process employed for tag products is ethylene oxide (eo) sterilisation, which is highly effective in eliminating such microorganisms.No causal link between the event and the device could be determined.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 21136388
• Report Number: 9612515-2025-00004
• Device Sequence Number: 6829642
• Product Code: DSY
• UDI-Device Identifier: 05037881106885
• UDI-Public: 05037881106885
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 733028
• Device Lot Number: 21726238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male