MAUDE Adverse Event Report: VASCUTEK LTD; GELWEAVE VALSALVA

Catalog Number	730030ADP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical trial panther_32 patient number (b)(6), 40 year old male patient had a relevant medical condition of aortic valve regurgitation with possible device failure / deficiency of suspected graft leakage, and possibly related to the procedure but not related to pre-existing condition and surgical intervention.Patient had aortic bleeding.Graft leakage on mri to be confirmed by ett.Graft leakage seen in imaging did not lead to a clinical event with a need for reintervention.No action was taken.Note: no leakage was observed in ct scans at previous visit in (b)(6) 2019.Patient has not attended any further follow up visits.Site have been contacted to determine current status/ outcome of patient.
Additional Manufacturer Narrative
Clinical code: 4580 insufficient information: additional information and pre/post op scans requested from site.Health effect: 2199 no health consequences or impact: graft remains implanted, graft leakage seen in imaging did not lead to a clinical event with a need for reintervention.Medical device problem: 3190 insufficient information: additional information and pre/post op scans requested from site.Type of investigation: 4114 device not returned: device remains implanted.3331 analysis of production record: all manufacturing and qc records reviewed, and device was built to speciation.4110 trend analysis: : a 5 year review of similar events for leakage? unknown leakage type? unknown location was performed which gave and occurrence rate of 0.001%.
Event or Problem Description
Clinical trial panther_32 patient number 100, 40 year old male patient had a relevant medical condition of aortic valve regurgitation with possible device failure / deficiency of suspected graft leakage, and possibly related to the procedure but not related to pre-existing condition and surgical intervention.Patient had aortic bleeding.Graft leakage on mri to be confirmed by ett.Graft leakage seen in imaging did not lead to a clinical event with a need for reintervention.No action was taken.Note: no leakage was observed in ct scans at previous visit in march 2019.Patient has not attended any further follow up visits.Site have been contacted to determine current status/ outcome of patient this report is being submitted as a final for mfg report fda 9612515-2023-00009 comp 5083.Additional information recieved from site on 09 aug 23 confirmed that this event was not device related.
Additional Manufacturer Narrative
Clinical code: 4580 insufficient information: additional information and pre/post op scans requested from site.Health effect: 2199 no health consequences or impact: graft remains implanted, graft leakage seen in imaging did not lead to a clinical event with a need for reintervention.Medical device problem: 3190 insufficient information: additional information and pre/post op scans requested from site.Type of investigation : 4114 device not returned: device remains implanted.3331 analysis of production record: all manufacturing and qc records reviewed, and device was built to speciation.4110 trend analysis: a 5-year review of similar events for leakage >> unknown leakage.Type >> unknown location was performed which gave and occurrence rate of (b)(4).4111 communication/ interviews: emailed site for additional information on this event.Investigation finding's: 213 no device problem found: email from site confirmed this event was not device related.Investigation conclusion: 67 no problem detected: email from site confirmed this event was not device related.

• Common Device Name: GELWEAVE VALSALVA
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 17478437
• Report Number: 9612515-2023-00009
• Device Sequence Number: 2905375
• Product Code: DSY
• UDI-Device Identifier: 05037881120133
• UDI-Public: 05037881120133
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 10/31/2021
• Device Catalogue Number: 730030ADP
• Device Lot Number: 17558775
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2018
• 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 Age: 40 YR
• Patient Sex: Male