MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE VALSLAVA

Model Number	GELWEAVE VALSALVA
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2022 a gelweave valsalva graft was mated with a perimount magna ease 27mm valve and implanted; but before the attachment of the coronary buttons, the clinician noticed three slit like holes on the skirt of the valsalva.The slits were described as looking as if they had been caused by a blade, they measured approx.5mm in length and approx.1cm apart going around the rv side.All three slits were repaired with pledgeted sutures and subsequent testing identified no leaks, no detriment to the patient, no bleeding due to these slits.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE VALSLAVA
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 14302854
• Report Number: 9612515-2022-00004
• Device Sequence Number: 14664362
• Product Code: DSY
• UDI-Device Identifier: 05037881120133
• UDI-Public: 05037881120133
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K013022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: GELWEAVE VALSALVA
• Device Catalogue Number: 730030ADP
• Device Lot Number: 17066058
• 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: 04/21/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• 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: Required Intervention
• Patient Sex: Male