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

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician used a 8mm gelweave graft on his bentall case today.The graft oozed all over it's entire surface area, for the entire case.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4580 - insufficient information: a/w additional information form site impact code: 4648 - insufficient information: a/w additional information form site medical device problem: 3190 - insufficient information: a/w additional information form site component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelweave sales v gelweave leakage events 24 jan 19 to jan 24 ) gave an occurrence rate of (b)(4) 4111 - communication interview: requested additional information 3331 - analysis of production records: full batch review performed.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4580 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Impact code: 4648 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Medical device problem: 3190 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: (b)(4).4111 - communication interview: requested additional information no additional information was received 3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products investigation findings: 213 - no device problem found: a full batch review from raw material to finished product was performed which showed no issues in the manufacture of batch 22331888.Investigation conclusion: 4315 - cause not established : no causal factor between the event and the device could be determined.67 - no problem detected : no issue was found in the manufacture of batch 22331888.
Event or Problem Description
Physician used a 8mm gelweave graft on his bentall case today.The graft oozed all over it's entire surface area, for the entire case this report is being submitted as a follow up#1 for manufacturing report #9612515-2024-00018 to provide closure information for (b)(4).
Additional Manufacturer Narrative
Clinical code: 4580 - insufficient information: 3 attempts( 1st mar 24 , 12 mar 24, 21 mar 21) were made to obtain additional information on this event, no additional information was communicated.Impact code: 4648 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Medical device problem: 3190 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelweave sales v gelweave leakage events (b)(6) 2019 to (b)(6) 2024 ) gave an occurrence rate of (b)(4).4111 - communication interview: requested additional information no additional information was received.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products.Investigation findings: 213 - no device problem found: a full batch review from raw material to finished product was performed which showed no issues in the manufacture of batch 22331888.Investigation conclusion: 4315 - cause not established : no causal factor between the event and the device could be determined.67 - no problem detected : no issue was found in the manufacture of batch 22331888.
Event or Problem Description
Physician used a 8mm gelweave graft on his bentall case today.The graft oozed all over it's entire surface area, for the entire case.This report is being submitted as a follow up#2 for manufacturing report #9612515-2024-00018 to provide fda response infromation.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review and remediation effort based on human error occurred in submission of mdrs as vmsr ( voluntary malfunction summary reporting) instead of individual reporting requirement to the fda.On 12th july 2024 vascutek were contacted by the fda and informed that the h1 section had been incorrectly filled in initial mdr submissions.The firm opened a non-conformance - ncr10893 to mitigate quality system management to address issue, employee training, and implement corrective actions.Ncr10893 was opened on 29 aug 24 and closed on 27 sep 24.There is no change to the device performance or risk profile.Manufacturer narrative: clinical code: 4580 - insufficient information: 3 attempts( 1st mar 2024 , 12 mar 2024, 21 mar 2021) were made to obtain additional information on this event, no additional information was communicated.Impact code: 4648 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Medical device problem: 3190 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelweave sales v gelweave leakage events 24 jan 2919 to jan 2024 ) gave an occurrence rate of (b)(4).4111 - communication interview: requested additional information no additional information was received 3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products investigation findings: 213 - no device problem found: a full batch review from raw material to finished product was performed which showed no issues in the manufacture of batch 22331888.Investigation conclusion: 4315 - cause not established : no causal factor between the event and the device could be determined.67 - no problem detected : no issue was found in the manufacture of batch 22331888.
Event or Problem Description
Physician used a 8mm gelweave graft on his bentall case today.The graft oozed all over it's entire surface area, for the entire case.Follow up#3 see narrative in section h11.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• 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: 18985073
• Report Number: 9612515-2024-00018
• Device Sequence Number: 14167659
• Product Code: DSY
• UDI-Device Identifier: 05037881105079
• UDI-Public: 05037881105079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2024

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 Expiration Date: 05/31/2025
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 731508-G
• Device Lot Number: 22331888
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 02/29/2024; 02/29/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/23/2024; 09/18/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2022
• 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
• Patient Sex: Unknown