MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE VALSALVA

Model Number	GELWEAVE VALSALVA
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Event was reported to vascutek ltd via clinical trial as allergic reaction to gelatin/polyester.Clinician indicated this event was not device related.(b)(6) 2021 : hypotension after surgical sternum closure due to vasoplegia caused by an allergic reaction repeat sternotomy for visual inspection performed, trendelenburg position + femoral arterial catheter for hemodynamic control event resolved on (b)(6) 2021.(b)(6) 2021 : urticarial rash resolved with medication.
Additional Manufacturer Narrative
(b)(4).Vascutek ltd.Considers this event as closed.Further action is not planned, however, the issue will be tracked and trended asas part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE VALSALVA
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 12745163
• Report Number: 9612515-2021-00023
• Device Sequence Number: 17263078
• Product Code: DSY
• UDI-Device Identifier: 05037881120133
• UDI-Public: 05037881120133
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K013022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 05/31/2024
• Device Model Number: GELWEAVE VALSALVA
• Device Catalogue Number: 730030ADP-G
• Device Lot Number: 21872544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention