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

Model Number PLEXUS

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Aneurysm (1708); Aortic Dissection (2491)

Event Date 06/23/2020

Event Type  malfunction  

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 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
• Type of Device: GELWEAVE PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 10312145
• MDR Text Key: 242660935
• Report Number: 9612515-2020-00006
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881106359
• UDI-Public: 05037881106359
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K060142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2020,07/23/2020

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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• 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
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR