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

Model Number	PLEXUS
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Codes	Aneurysm (1708); Aortic Dissection (2491)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Communication/interviews - from further questioning it was indicated that the device was not pre-soaked in saline or any other medium prior to use as recommended in ifu cautions.A 5-year review of previous similar events for gelweave graft gave an occurrence rate of (b)(4) (complaints v sales).A review of qc and manufacturing records showed that the batch was manufactured to design specification.All testing including physical test of base material met all acceptance criteria - all pre-release leakage testing was well within product acceptance criteria.No additional reports of leakage were received for any other devices in this batch.Vascutek now considers this complaint closed.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
Event or Problem Description
Patient admitted for acute type a dissection debakey type i based on a pre-existing ascending aneurysm, no anticoagulation treatment in medical history, emergent arch replacement.Patient underwent aortic arch replacement under hypothermic circulatory arrest (25 °c) and bilateral antegrade cerebral perfusion.After weaning from cardiopulmonary bypass and adequate substitution of protamine, progressive leakage of prosthesis in the area of first side branch of plexus prosthesis and along black suture mark of main body.Clinical relevant blood loss, despite massive substitution of fibrinogen, thrombocytes, protamine, desmopressin and fresh frozen plasma no improvement of leakage over three hours.Additional local fibrin glue and other hemostyptic material applied on top of prosthetic material.After wound closure no relevant bleeding, patient is extubated and clinical stable.Patient received massive substitution of blood and coagulation products but tolerated all very well.Operative time was prolonged but patient recovered uneventful.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10312145
• Report Number: 9612515-2020-00006
• Device Sequence Number: 16391630
• Product Code: DSY
• UDI-Device Identifier: 05037881106359
• UDI-Public: 05037881106359
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K060142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2020
• Report Date (Section F): 06/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: PLEXUS
• Device Catalogue Number: 73301088/8
• Device Lot Number: 17076229
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/23/2020
• 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
• Patient Age: 67 YR